Good day, and thank you for standing by. Welcome to the Q1 2026 Coheris 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 the session, you will need to press star 1, 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1, 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, and welcome to Colheris Oncology's first quarter, 2026, Ernie's Conference Call. Joining me today to discuss our results are Denny Lancer, Chief Executive Officer of Colheris, Dr. Rosh Dias, Chief Medical Officer, Dr. Teresa Lavallee, Chief Scientific and Development Officer, Samira Ghorigoker, Chief Commercial Officer, and Brian McMichael, Chief Financial Officer. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coheris' 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. And 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 with the company's strategy to make sure we level set everyone, including our new investors. That strategy starts with Bactorzi, 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 casdozo ketoc, which we are exploring in liver cancer, and tegmo ketoc, 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 lactorazine'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 Lactorsi with the Pipeline ASLIT translates to a two-for-one win. Label expansion for Lactorsi 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 Tagmo-Ketog 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 Tregs gone awry. Our strategic objective, then, is to broadly deploy TGMO-TG across cancers and non-proprietary therapies. Last quarter, we concluded the first such arrangement with J&J in prostate with PASRI, a T-cell engager. We are currently exploring other partnering opportunities, which include with not just T-cell engagers, but ADCs, radiotherapy, and various biospecifics. Now, 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. And the right target translates to immune context and the nuances of the biology. 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, Teresa Lavallee, to spend a few minutes with you today and provide a lens through which to view the fields evolution. I hope you find it useful. Also today, Raj Dias, our Chief Medical Officer, will update you on the trials, the enrollment, and the timing results. Sameergoa Gecko will review the Q1 revenues as well as provide an update on our commercial execution. We continue to project that we will have some $15 million per quarter sometime this year in 2026 and 30 to 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 samir brian mcmichael will review for you our financials and with that now let me turn the call over to Raj. Dr. Gaius?

Thank you, Jenny, and good afternoon, everyone. We continued to advance our highly focused clinical development program for our pipeline molecules, Padova-Tetoc and Tagma-Tetoc-321, and we're pleased with our progress in both molecules, with Accrual progressing well, and we are tracking to plan. Recently, we announced that we had completed our target Accrual to our Catalyze-202 randomized study in footline hepatocellular carcinoma. As a reminder, this is a 72-patient, three-armed study investigating two active doses of caldozo in combination with toripalumab and bevacizumab versus toribevolone, and is designed to further characterize the efficacy and safety of this triplet, as well as address FDA's Project Optimus and contribution of components. This study builds upon the previous data we presented last year at ASCOGI, where the combination of caldozo on top of the current standard of care of the T-Zo and Bev demonstrated an overall response rate of 38 percent and a very encouraging complete response rate of 17 percent both of which are greater than the historical data for atezobev alone of 30 percent and 7.7 percent respectively patient accrual has gone well and we anticipate having initial data available around the mid-year time frame as projected given what we observed in the prior casdozo hcc trial we expect the response data to mature over time after that perhaps quarter to quarter moving to tagmatita our ccr-8 cycleytic antibody we're currently running two active protocols in a targeted clinical program in tumor types where ccr-8 intratumoral expression levels and and the demonstration of activity previously in the ccr-8 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 variable 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 a 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 TORI, irrespective of PD-L1 status, is particularly marked and forms the basis of TORI's approval in Europe as the only PD-1 approved across all PD-L1 levels in this tumor type. We're investigating the TAGMO-TORI combination in second-line ESCC, and in first-line ESCC, we're exploring TAGMO and TORI in combination with chemotherapy as a safety cohort. Cohort D is exploring TAGMO and TORI 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 JNJ-Pasrhythmic 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 end this fall. With that, I will hand it over to Teresa. Teresa?

Thank you, Rush, and good afternoon. Today, I will cover three topics. Two aspects for TAGMO ketogs. As the CTR8 competitive field is evolving, I will briefly review the importance of pharmacology and drug development. And then I will review our own TAGMO-KETUG pharmacology data to date. These data have supported the opportunity to expand TAGMO-KETUG development with J&J T-cell engager Pazritamig, 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. So let me start with reviewing some of our analysis plans for the CASDO-KETUG randomized catalyzed 202 study. Having the CASDO-KETUG 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 Casdo-Ketug. The previous Casdo-Ketug HCC study provided a small data set suggesting that higher levels of IL-27 expression in tumors were associated with response. However, 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 have trained pre-treatment 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, TAGMO-KETUG, 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 decay and potency, showing you can deliver the drug at the needed exposure, and thirdly, dose-dependent effects on the intended target, showing the drug has hit the target and affected the target as related to dose, and fourthly, an acceptable safety profile alone in combination. The majority of the CCR8 antibodies aim for a bind-and-kill MOA to deplete intratumeral 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, and 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 AMG355 and pembrolizumab. From the 12 with gastric cancer, one partial response was observed. These results contrast with the gastric cancer data from Lenovo, now Sinobiopharma, where LM108, in combination with PD-1 inhibitors, demonstrated a 36% overall response rate. Gilead, in contrast, showed antitumor activity, including single-agent activity, and tumor types known to have a high degree of CCR8-positive Tregs. Gilead is now advancing their deniketug into Phase II development in multiple studies, and we await additional data sets. In summary, it would seem that many CCR-8 programs that are stopping are doing so due to drug-like properties falling short and failing the right drug criteria. In contrast, Tagmo-Ketog has shown good pharmacology and has met all the criteria for right drugs. 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 torapalimab. 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 combinations for the best efficacy across cancers, lines of therapy, and immune context. We are evaluating TAGMO-KETUG in combination with either toropelumab, a PD-1 inhibitor, or pathritimic, a T-cell engager. We plan to evaluate TAGMO-KETUG in other combination where Tregs are associated with therapy resistance, such as ADCs or radiotherapy. We believe this will inform our development broadly across anti-cancer therapies on the best way to overcome TREG-driven resistance in cancer patients. With that, I'll turn the call over to our Chief Commercial Officer, Shamir.

Thank you, Teresa, and good afternoon, everyone. Today, let me offer you some color on our Q1 results, what we saw with respect to demand signals, and our focus going forward to drive growth. In Q1-2026, Loftrosi 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 Q4-25. This result was consistent with typical first-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 LOCTOSI revenue growth to build through the remainder of 2026, given a closer analysis of our growth drivers. We are pleased to report that LOCTOSI new starts reach an all-time high in Q1. This was driven by, one, broader prescribing in new accounts, and two, deeper use to 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. First, we're focusing on reducing chemo-only use, particularly in a community setting, through continued education on NCCN guidelines and our Phase III data, including the six-year long-term survival benefit analysis. Secondly, 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 Loctrosi's position as the only approved and available immune therapy in NPC, offering a superior survival benefit over chemotherapy alone. We are moving this plan forward, utilizing targeted investments to enhance our execution. Importantly, new claims data purchasers have expanded our visibility into chemo-only and off-label IOUs 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 Insight 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 adoption by oncologists and are increasingly used to drive treatment decisions. Regarding our guidance, we continue to expect 10 to 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 duration of treatment. With that, I'll now turn the call over to Brian McMichael, a Chief Financial Officer.

Thank you, Samir, 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 underwriters over allotment option. These funds have strengthened our liquidity position and are supporting the new Tagno Key Tug, CRC, and prostate studies, enhanced investments in Loctorzi commercialization capabilities to reach revenue targets faster, and general corporate purposes. Regarding sales, in addition to the color on Loctorzi net revenues provided by Samir, 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 Coheris' complete exit from the biosimilar business, which, as we talked to you today, was completed more than one year ago. Now turning to the balance sheet. Total cash, 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 rate outs in 2026 and 2027. With that, I'll hand the call back over to Denny.

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

Thank you. If you wish to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. We will take our first question, and the first question comes from the line of Jay Olsen from Oppenheimer. Please go ahead. Your line is open.

Oh, hey, thank you for providing this update and for taking our questions. On Loctorzi, 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 first-line patients? And then related to that, congrats on the new patient starts in the first quarter. Can you maybe share some color on how the patients split between first and second line and where should we eventually expect the percentage of patients on loctorase in the first-line setting? And then if I could, I have a follow-up on TAGMO, please.

Thank you, Jay. I'll let Samir unpack that for you. Samir, would you like to address Jay's question about the treatment duration and so on?

Thank you, Jay. Thanks for the question. And you had a couple of points to that question, so just to 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. And then, yeah.

So 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 a first-line metastatic patient. And the second type of patient is a monotherapy patient, which is the later-line metastatic patients. We, in the clinical trials in the real world, we're seeing higher duration of therapy for the first-line patients than the second-line model therapy patients. In terms of new and existing patients, I think it's the same dynamic playing out for both the new and existing patients. So 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. And the next question was about new patient starts in first line and second line. So currently we're seeing about 75% to 80% of our patients are coming from the metastatic setting, both the frontline metastatic setting and the second line metastatic setting, and a smaller percent of patients coming from the locally advanced recurrent setting. And that's in line with physicians initially at launch, putting patients on the later line patients, and then moving the use of therapy to an early alliance setting. As we get further into the launch, we would expect that we get more locally advanced recurrent patients. And 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 lock-to-all.

Thank you, Jay, and thank you, Samir. Thank you.

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 mid-year, could you just talk about what investors should expect to learn from those two updates, and will you be providing next steps in the clinical development for those two programs?

Russ, do you want to take that one about the data? And then, Teresa, you can take the next steps.

Thank you, Jay, for the question. So, in terms of data readouts, yeah, so we anticipate initial data for the second line head and neck and the second line upper GI adeno around the mid-year timeframe. A 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. So, again, for the number of patients, I anticipate more than 50% or more of patients. The 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. And as you know, the real benefit of I.O. has been in extending that tail. So I'd look out for those key metrics to start with.

Great. Thank you very much. Yeah, and I think just to add to that, Jay, because we're super excited to think about next steps. And so 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, because the regulatory endpoints are survival. So 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. So we'll be looking for both of those outputs and directions from the studies as they read out.

Great. Thank you so much. Looking forward to it.

We're ready for the next question, operator.

Thank you. Your next question comes from the line of Paul Jang 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 from patient demographics. Can you speak to what proportion of patients you would expect to be PD-1 experienced? And do you plan to break out responses by HPD status? And then how do you think about the bar?

Okay, hold on, Paul. Yeah, Paul, well, let's stop there and just do one question. Let's answer that, then we can follow on. Teresa, Raj, can you create that?

Yeah, I can tell you that. So, thanks, Paul, for the question. So, yes, all of the patients in the second-line head next study will be pdl pd1 or pdl1 experienced um and yes one of the key stratification factors is uh the hpv status did you agree yeah so i guess i did yeah so 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 um i can take that one as well so um 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 rate tends to be in the 13% to 15% ORR range. You're absolutely right. We do see the environment changing and evolving with the EGFRs. And a couple of points I'll mention. So, 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. And secondly, you know, I think the majority of the benefit is really driven by HPV negative status. And so, you know, I think that also leaves the HPV positive patients, which accounts for roughly about 40% of subjects overall pretty wide open. So, I think that's the way we kind of look at the current benchmarks and the evolving data sets. Tracy, have additional comments?

Yeah, and we're actively watching it, obviously, with announcements from the NECD and ADC data. That's super exciting. Shows a rapid development path in the head and neck space. Then Hibbrick's 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. And 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. So, in addition to streamlining our development with a way to advance the 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. We will take the next question. please stand by. Your next question comes from the line of Brian Cheng from JP Morgan. Please go ahead. Your line is open.

Hi, guys. Thanks for taking our questions this afternoon. Maybe just first on Lactorsi, 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 Lactorsi? Is there access issue because of weather. And just, you know, just on top of that is how do we reconcile that dynamic with the record new patient start that you're seeing this quarter? And we have a follow-up. Thank you.

Okay. Thanks, Brian.

Samir, you want to take that? Yeah. Thank you, Brian, for the question. So, 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 kind of early to understand that. So, 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, and we took a basket of 85 oncology molecules. And really interestingly, for the last four years, this basket, we saw a very consistent 5% decline from Q4 to Q1. And what we didn't expect is a larger magnitude of decline in 2026, where we saw a 10% decline for that basket from Q4 to Q1. So it's like, as we expected, it's a pretty consistent decline pattern in Q1. and then most products go back to growth in Q2. So we're following a similar pattern it looks like, right? That being said, in terms of reconciling the new patients and the existing patients, so 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. And I think what happened is a lot of patients who are on either three-week cycles or two-week cycles missed their cycles. And as a result, we lost that entire cycle for a big chunk of patients, and they reset their cycle clock. So we lost these individual cycles for a chunk of patients. That is totally separate from the new patient starts, right? Because 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 going to become the existing patient for future quarters. So those are the two dynamics in that play we saw.

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

Yeah, we do. Maybe just on the 202 study, Teresa, you talked about how, you know, the influence of circulating tumor DNA and also IL-27 expression in the upcoming data, you know, in terms of figuring out the association of those expressions to tumor reduction. Do you have a sense, based on preclinical models, do you have a sense of how correlated that they are, you know, in terms of the magnitude of IL-27 reduction to tumor reduction in preclinical Thanks, Brian.

Yeah, and 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. and given the amount of IL-27 that's expressed there, that comes through. And 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 several times, is that it's an initial readout. The first readout in the Catalyst 201, the previous Vietezo-Bev study, the overall response rate was only 27%. But a lot of patients were on study and we saw tumor shrinkage deepening. And 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 matured.

Thank you. Thank you, Brian. 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 Cousy from Baird. Please go ahead. Your line is open.

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

Yeah, thanks, Nick, for the question. So I think you'll recall that we talked about Hepatorch, which is the study of Tori Palamab and Bev versus Serafinib, and that really showed very similar, if not slightly higher, overall survival compared to Atizabev, obviously not a head-to-head. So I think we have confidence in that. And the other thing I'll say is that the ADA rate for Atizo tends to be a lot higher than the Tori Palimab. So I think those two points really give us some confidence that the Tori Bev is a good backbone on which to add Casdozo-Ketan.

And the safety profile has been quite good. That's actually one of the standouts, particularly in this disease and the frontline HCC study. And Casdozo across the board really hasn't added any additional or new toxicities to any treatment, whether it be Atezo, whether it be Tori, whether it be Pembro, that has been evaluated to date.

Great, thank you.

Thank you. We will take our next question. Your next question comes from the line of Mike Nedokovic from TD Cohen. Please go ahead. Your line is open.

Thanks for the questions. I'll start with my first on TAGMO-KITUG. Theresa, you alluded to this in your remarks, but I believe Lenovo has initiated a Phase 3 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? And to the extent that you can speak to specific similarities or differences between their molecule and approach to TAGMO-KETUG, that would be super helpful.

Thanks for that, Mike.

Yeah, I love this question. And I think this is really important because we see programs advancing and programs stopping. Sino Biopharma with LM108, our half-filled keyboard, has started two Phase 3s. In fact, last week they announced dosing the first patient in the gastric cancer Phase 3. They also have an MSI-high CRC study as a pivotal study ongoing. So they really have confidence in 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 to Phase II randomized study, gastric cancer, colorectal cancer, and BMS continuing to add patients to their study. So we think that the differences, you know, from the programs that are being parked or the negative data, that the lack of activity that AMZEN showed comes down to pharmacology. So 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 Lactorsi, if that's okay. Sure. I'm just curious, given that you now have a better sense of seasonality, do you still think Lactorsi can get to that roughly $30 to $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 26. Second, reaching $30 to $35 per quarter sometime in 27. And then thirdly, reaching what would be an annualized $175 million per year, which is about $44 million a quarter sometime in 2028. And 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. appreciate the update. Thank you. 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. And the question comes from Douglas Sauer from HC Wainwright. Please go ahead. Your line is open.

Sorry. Can you hear me?

Yes. Hello. Can you hear me? Hi, Doug. Yes, Doug. Hello. Sorry about that. I had you on a mute at first. Just thanks for taking the questions. I guess just maybe on the lactose 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 patient's ongoing therapy? And should we think of this as just sort of purely deferred revenue that eventually should catch up for the rest of the year?

Samir, you want to take that one for us? Doug? I'll take a shot at that. Thank you, Doug, for the question. So I think the first part of that question is, it did affect our, I believe it affected our existing patients. New patients, as 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. So 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. So that's where we lost some cycles. I don't think we're going to get those cycles back because if you're on a three-week cycle and you missed your cycle this week, you basically go back on a new three-week cycle so that one cycle is lost basically forever. But again, let me just kind of go back to what we said earlier, right? So that's Q1, right? So 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, Samir. 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, are you able to, and I think you would certainly play to succeed or assume that you're going to succeed with these studies, do you think that you're in a position to continue to sort of prosecute all these opportunities, or is there some prioritization that might need to happen?

I would direct you back to my prepared remarks at the beginning of the call, but we are certainly funded through the 26 and all the 27 turning over of all the data cards. One thing that we do is if we have an unfunded clinical trial or we have something that we believe is worthwhile, we take it to our investors. And currently, all of our clinical trials are funded. We just raised, as you know, and that really addressed the issues of the CRC study, which were not funded, as well as the prostate study with J&J, both of which I think you'd agree are very worthwhile. So 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 TACNO-KETUG and a very highly focused program with respect to Kezdozo-KETUG. So 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. And 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 Jeffrey's, what 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.