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DATE

Monday, May 11, 2026 at 5 p.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Dennis M. Lanfear
  • Chief Medical Officer — Rosh Dias, M.D.
  • Chief Scientific Officer — Theresa M. Lavallee, Ph.D.
  • Chief Commercial Officer — Sameer Goregaoker
  • Chief Financial Officer — Bryan J. McMichael

TAKEAWAYS

  • Loqtorzi Net Sales Growth -- $11.8 million in Q1, up 61% year over year but down from $12.4 million in Q4 2025, reflecting seasonality and severe winter storm impacts.
  • Record Loqtorzi New Starts -- New patient starts reached an all-time high, supported by a 21% increase in breadth and depth of ordering accounts and an ongoing increase in treatment duration quarter over quarter.
  • Quarterly Demand Growth Guidance -- Management projects 10%-15% demand growth per quarter on average for Loqtorzi in 2026, excluding future quarterly revenue guidance which will be provided in August.
  • Future Loqtorzi Revenue Milestones -- CEO Lanfear stated, “We will hit some $15 million per quarter sometime this year in 2026, and $30 million 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.”
  • CATALYST-202 Study Accrual -- Accrual completed for the randomized 72-patient CATALYST-202 study in first-line hepatocellular carcinoma; initial data readout anticipated midyear.
  • PIPELINE Clinical Progress -- Enrollment remains on track across multiple tagmoketug and casdozoketug studies, with several midyear and second-half 2026 data readouts planned.
  • Operating Expenses -- R&D expenses were $21.5 million, and SG&A expenses were $23.1 million in Q1, both reduced versus the prior year, reflecting headcount/infrastructure savings and biosimilar business exit, partially offset by pipeline investment.
  • Liquidity Position -- Cash, cash equivalents, and investments were $167 million at quarter end, with a $54 million net equity raise completed including overallotment; management states funding is sufficient through key data readouts in 2026 and 2027.
  • TAGMO Clinical Readouts -- Initial results for head and neck, and upper GI adenocarcinoma cohorts are expected midyear, with 50% or more patients included; additional readouts in ESCC and metastatic colorectal carcinoma are planned for second half of 2026.
  • Market Opportunity -- Management targets $33 billion in addressable market opportunity through current pipeline and commercial efforts, primarily via Loqtorzi and Treg depletion strategies.

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RISKS

  • Severe winter storms led to missed Loqtorzi dosing cycles for existing patients, which Sameer Goregaoker said, I do not think we are going to get those cycles back.
  • Management notes some market participants are pausing or stopping their programs due to drug-like properties falling short in the competitive field.

SUMMARY

Loqtorzi achieved its highest-ever patient starts in Q1, outpacing prior quarters despite a year-over-year revenue increase of 61% being offset sequentially by seasonal and weather-related declines. Management reiterated guidance for reaching $15 million in quarterly Loqtorzi sales during 2026, with further milestones of $30 million-$35 million per quarter by 2027 and $44 million per quarter at peak. The CATALYST-202 trial in first-line hepatocellular carcinoma completed enrollment, enabling a midyear data readout with an expanded biomarker strategy centered on IL-27 and circulating tumor DNA. Execution visibility has improved through expanded claims data coverage, supporting more precise field targeting and digital engagement initiatives.

  • Management affirmed cash from the recent $54 million equity raise fully funds all current clinical trial programs—including new expansion cohorts—through data readouts into 2027.
  • The company’s clinical pipeline saw continued progress, with multiple ongoing studies in casdozoketug and tagmoketug, and several midyear and second-half data releases scheduled, including new combination studies such as the J&J pasritamab cohort for tagmoketug.
  • Guidance and Q1 results reflect a significant realignment toward oncology, with SG&A expense reductions following the company’s completed exit from the biosimilar business more than a year prior.
  • Competitive developments in the CCR8 antibody space were highlighted by the halting of some peer programs, contrasted by management’s emphasis on tagmoketug’s positive pharmacological attributes and progression.

INDUSTRY GLOSSARY

  • NPC: Nasopharyngeal carcinoma, a specific cancer indication driving Loqtorzi's current commercial traction.
  • Treg Depletion: Therapeutic strategy targeting regulatory T cells (Tregs) in the tumor microenvironment to enhance anti-tumor immune activity.
  • CATALYST-202: Coherus’ randomized phase 2 study of casdozoketug in first-line hepatocellular carcinoma (HCC), assessing efficacy in combination with toripalimab and bevacizumab.
  • TAGMO / tagmoketug: Coherus’ CCR8-targeting cytolytic antibody under clinical evaluation across multiple cancer types.
  • CCR8: C-C chemokine receptor type 8, a receptor selectively expressed on tumor-infiltrating Tregs, serving as the target for immune-modulating antibodies like tagmoketug.
  • PD-1 inhibitor: Programmed death receptor-1 inhibitor, a class of immunotherapy drugs; Loqtorzi and toripalimab are examples discussed in the call.
  • ESCC: Esophageal squamous cell carcinoma, a cancer subtype targeted in ongoing tagmoketug clinical trials.
  • ADCs: Antibody-drug conjugates, therapeutics combining an antibody with a cytotoxic payload, referenced as combination partners for future development strategy.

Full Conference Call Transcript

Dennis Lanfear: 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 casdozoketug, which we are exploring in liver cancer, and 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 at peak share, which does not include clinical trial costs, something which we do separately. Proprietary combinations of Loqtorzi with the pipeline asset translate to a two-for-one win, with 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 Treg depletion with tagmoketug across cancers and across nonproprietary 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 tagmoketug across cancers and nonproprietary therapies. Last quarter, we concluded the first such arrangement with J&J in prostate with pasrutinib, a T cell engager.

We are currently exploring other partnering opportunities which include not just T cell engagers, but ADCs, radiotherapy, and various bispecifics. Now, we have been saying for some time across all of our presentations that 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 has become clear that the therapeutic promise of Treg depletion notwithstanding, some market participants are pausing or stopping their programs while others are accelerating and expanding their programs.

It is essential for all of us to understand the nuances playing out. Accordingly, I have asked my Chief Scientific Officer, Theresa M. 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 of 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 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 Sameer, Bryan J. McMichael will review our financials. And with that, let me turn the call over to Rosh. Rosh?

Rosh Dias: Thank you, Denny, and good afternoon, everyone. We continued to advance our highly focused clinical development program for our pipeline molecules, casdozoketug and tagmoketug, through Q1, and we are 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, three-arm study investigating two active doses of casdozo in combination with toripalimab and bevacizumab versus toripalimab/bevacizumab, and it 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 ASCO GI, where the combination of casdozo 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 midyear timeframe 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 tagmoketug, our CCR8-cytolytic antibody, we are currently running two active protocols in a targeted clinical program in tumor types where CCR8's 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 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 a fourth-line patient. The 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 midyear timeframe. 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 midyear 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 are investigating the TAGMO/Tori combination in second-line ESCC, and in first-line ESCC we are 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 metastases, 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 have made excellent progress on the J&J pasrutinib T cell engager combination cohort of TAGMO in prostate cancer, which will be the first of a new multicohort protocol, 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?

Theresa M. Lavallee: Thank you, Rosh, and good afternoon. Today, I will cover three topics. First, two aspects for tagmoketug as the CCR8 competitive field is evolving. Second, I will briefly review the importance of pharmacology in drug development. Third, I will review our own tagmoketug pharmacology data to date. These data have supported the opportunity to expand tagmoketug development with the J&J T cell engager pasritamab, a novel combination with CCR8-depleting antibodies and a potentially complementary anticancer therapy. We are excited this is our first nonproprietary combination to advance in clinical development. Let me start with reviewing some of our analysis plans for the casdozoketug randomized CATALYST-202 study.

Having the casdozoketug 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 casdozoketug. The previous casdozoketug HCC study provided a small dataset suggesting that higher levels of IL-27 expression in tumors were associated with response. However, we had just seven tumor samples, 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 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, tagmoketug, 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 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; dose-dependent effects on the intended target showing the drug has hit and affected the target as related to dose; and an acceptable safety profile alone and 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, 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 AMG-355 and pembrolizumab. From the 12 with gastric cancer, one partial response was observed. These results contrast with the gastric cancer data from Lenovopharma, now Synovia Pharma, 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 dedikitug into phase two 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, tagmoketug has shown good pharmacology and has met all the criteria for right drug: excellent linear, dose-dependent PK; potency for both binding and killing the target; dose-dependent immune effects; and an 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 tagmoketug in combination with either toripalimab, a PD-1 inhibitor, or pasritamab, a T cell engager. We plan to evaluate tagmoketug in other combinations where Tregs are associated with therapy resistance, such as ADCs or radiotherapy. We believe this will inform our 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. Thank you.

Sameer Goregaoker: 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, 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 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 5% decline from Q4 to Q1 over the past four years.

However, in 2026, the decline for the basket was more pronounced at 10%, likely driven by the severe winter storms that hit most of the country. With the 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 broader prescribing in new accounts and deeper use with 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 are focusing on reducing chemo-only use, particularly in the community setting, through continued education on NCCN guidelines and phase three data, including the six-year long-term survival benefit analysis. Secondly, we are 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 immunotherapy 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 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 multichannel execution. Our inside sales team is now fully operational, significantly expanding our reach into the community setting, a key growth driver. We are 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 will now turn the call over to Bryan J. McMichael, our Chief Financial Officer.

Bryan J. McMichael: Thank you, Sameer, and good afternoon, everyone. I will 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 the 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 tagmoketug 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 Oncology, Inc.'s complete exit from the biosimilar business which, as we talk 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 were $167 million, down slightly from $172.1 million at year-end. Given the recent raise and our financial plans, we believe we are sufficiently funded through key data readouts in 2026 and 2027. With that, I will hand the call back over to Dennis.

Dennis Lanfear: Thank you, Bryan. Operator, we are ready to go to the questions.

Operator: We will now open the call for questions. If you wish to ask a question, you will need to press 1-1 on your telephone and wait for your name to be announced. 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.

Jay Olson: 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 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 Loqtorzi in the first-line setting? Then if I could, I have a follow-up on TAGMO, please.

Dennis Lanfear: Thank you, Jay. I will let Sameer unpack that for you. Sameer, would you like to address Jay's question about the treatment duration and so on?

Sameer Goregaoker: Thank you, Jay. Thanks for the question. You had a couple of points to that question, so just to make sure I got it correctly. The first question was the average duration of treatment and how that is split between new and existing patients, correct? Yes. 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 patient, and the second type of patient is a monotherapy patient, which is a later-line metastatic patient.

In the clinical trials and in the real world, we are seeing higher duration for the first-line patients than the second-line monotherapy patients. In terms of new and existing patients, it is the same dynamic playing out for both the new and existing patients. So, across the board, we are seeing that the duration continues to grow as we get further away from launch, and eventually, hopefully, we will get close to the clinical trial duration.

On new patient starts in first line and second line, currently we are seeing about 75% to 80% of our patients 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 local advanced recurrent setting. That is in line with physicians initially at launch putting patients on later-line therapy, 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. Lastly, we also now have visibility into where these patients are.

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

Dennis Lanfear: Thank you, Jay, and thank you, Sameer.

Jay Olson: Thank you. That is super helpful. Next question—could I ask you—sorry—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 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?

Dennis Lanfear: Rosh, do you want to take that one about the data? And then, Theresa, you can take next steps.

Rosh Dias: Thank you, Jay, for the question. In terms of data readouts, we anticipate initial data for the second-line head and neck and the second-line upper GI adeno around the midyear timeframe. A couple of things I will say. First, we anticipate at least 50% of the patients to be reported. As you think about the data and timing, there are probably two key determinants: number one is the number of patients; number two is the number of scans that may be needed to show activity. For the number of patients, I anticipate 50% or more. In terms of the number of scans, that is a little bit more variable.

We will be looking at overall response rate, clinical benefit rate, and safety, but duration will take a little bit longer to really mature. And as you know, the real benefit of IO has been in extending that tail. So I would look out for those key metrics to start with.

Theresa M. Lavallee: Thank you very much. To add to that, Jay, we are super excited to think about next steps. As we look at the data, particularly with durability—ORR is nice; it is 30% or greater tumor shrinkage—but durability is what matters because the regulatory endpoints are survival. So we will be thinking about whether there is sufficient efficacy to support favorable regulatory strategies, which all of these studies are designed, if the signal is there, to have sufficient patients to do that. Additionally, we will assess whether there is a patient population or a way of enriching patients.

Another output we are really looking at is the immune context and whether there is a way then to advance into a study to look more toward later-stage development. We will be looking for both of those outputs and directions from the studies as they read out.

Jay Olson: Great. Thank you so much. Looking forward to it.

Dennis Lanfear: We are ready for the next question, operator.

Operator: Thank you. Your next question comes from the line of Analyst from Guggenheim. Please go ahead. Your line is open.

Analyst: 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 will 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 HPV status? And then how do you think about the—

Dennis Lanfear: Okay. Hold on. Let us stop there and just do one question. Let us answer that, and then we can follow in. Theresa or Rosh, do you want to take that?

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

Analyst: I did have a follow-up question. I just wanted to ask about how you are 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.

Rosh Dias: I can take that one as well. First, the current standard of care is pretty dismal in terms of overall response rate. It is cetuximab, and that overall response rate tends to be in the 13% to 15% ORR range. You are absolutely right that we see the environment changing and evolving with the EGFRs. A couple of points I will mention. There are 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, I think the majority of the benefit is really driven by HPV-negative status, and so that also leaves the HPV-positive patients, which account for roughly about 40% of subjects overall, pretty wide open.

That is the way we look at the current benchmarks and the evolving datasets.

Dennis Lanfear: Theresa, any additional comment?

Theresa M. Lavallee: Yes, and we are actively watching it, obviously, with announcements from the nectin ADC. The data that are super exciting show a rapid development path in the head and neck space. The EGFR data coming out really show a non-EGFR approach in the frontline setting and show room and interest for novel agents. What we find particularly interesting about this mechanism—initial output is with PD-1 and TAGMO—and to your question, the first study is asking whether we can rescue PD-1 resistance, since they are 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 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.

Dennis Lanfear: Thank you very much. Heidi, we are ready for the next question.

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

Brian Cheng: 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? And just on top of that, how do we reconcile that dynamic with the record new patient starts that you are seeing this quarter? We have a follow-up. Thank you.

Dennis Lanfear: Okay. Thanks, Brian. Sameer, do you want to take that?

Sameer Goregaoker: Yes. Thank you, Brian, for the question. We are now into the third year of our launch, so we are getting a better sense of the seasonality patterns. We saw some seasonality last year; it was early to understand it. This year, again, we saw the seasonality, and that is why we dug into an analysis of what is really happening in the oncology setting. We took a basket of 85 oncology molecules, and, interestingly, for the last four years this basket showed a very consistent 5% decline from Q4 to Q1. What we did not expect is a larger magnitude of decline in 2026, where we saw a 10% decline for that basket from Q4 to Q1.

It is a pretty consistent decline pattern in Q1, and then most products go back to growth in Q2. We are following a similar pattern, it looks like. That being said, in terms of reconciling the new patient and the existing patients, we believe there were two major winter storms which affected about two to three weeks throughout the first quarter. 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 an individual cycle for a number of patients. That is separate from the new patient starts.

New patients are really important for us to drive future growth, and we are excited that we saw robust new patient growth, which is going to become the existing patient base for future quarters. The other point I will add is that last year, Q4 to Q1, we went down about 3%. This year it is about 5%. Given the storms, that is pretty much in line. Given the starts, we think we should get back on the growth curve this quarter.

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

Theresa M. Lavallee: Thanks, Brian. The preclinical models do not have a good readout there. What we have seen in the mouse is that it is very tissue specific, so the tumors have to be in the lung or the liver, and given the amount of IL-27 that is expressed there, that comes through. The things that we are really looking for—just to set expectations for the midyear readout—we have talked about this several times: it is an initial readout. The first readout in the CATALYST-201, the previous atezo/bev study, the overall response rate was only 27%, but a lot of patients were on study, and we saw tumor shrinkage deepening.

That is where we think that the initial readout with trends in circulating tumor DNA, as well as looking at whether there are differences in 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.

Dennis Lanfear: Thank you. Thank you, Brian.

Bryan J. McMichael: Alright. Heidi, we are ready for the next question.

Operator: Thank you. We will take our next question. Your next question comes from the line of Nick Quartapella from Baird, on for Colleen Kusy. Please go ahead. Your line is open.

Nick Quartapella: Hey, everyone. It is Nick on for Colleen. Thanks for taking the question. I just had a quick one on the casdozo program. Between atezo/bev and tori/bev as the backbone in combination, do you expect to see any differences in the efficacy or safety profile? Thank you.

Rosh Dias: Thanks, Nick, for the question. You will recall that we talked about HEPATORCH, which is the study of toripalimab and bev versus sorafenib, and that really showed very similar, if not slightly higher, overall survival compared to atezo/bev, obviously not a head-to-head. So we have confidence in that. The other thing I will say is that the ADA rate for atezo tends to be a lot higher than for toripalimab. Those two points give us some confidence that tori/bev is a good backbone on which to add casdozo.

Theresa M. Lavallee: And the safety profile has been quite good. That is actually one of the standouts in this disease. In the frontline HCC study, casdozo across the board really has not added any additional or new toxicities to any treatment, whether it be atezo, tori, or pembro, that has been evaluated to date.

Nick Quartapella: Great. Thank you.

Sameer Goregaoker: Thank you.

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

Michael Thomas Nedelcovych: Hi. Thanks for the questions. I have two. I will start with my first on tagmoketug. Theresa, you alluded to this in your remarks, but I believe Lenovopharma has initiated a phase three 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 approach and tagmoketug, that would be super helpful. Thanks.

Dennis Lanfear: Thanks for that, Mike. Theresa?

Theresa M. Lavallee: Yes, I thought this question was important, because we see programs advancing and programs stopping. Synovia Pharma with LM-108—formerly Lenovopharma—has started two phase threes. In fact, last week they announced dosing the first patient in the gastric cancer phase three. They also have an MSI-high CRC pivotal study ongoing. They really have confidence—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 two randomized studies in gastric cancer and cholangiocarcinoma, AbbVie advancing in colorectal cancer, and BMS continuing to add patients to their study.

We think that the differences—from the programs that are being paused or the negative data, the lack of activity that Amgen showed—come down to pharmacology. So we are excited about seeing programs advancing and seeing the properties of our molecule really making it exciting to look at the data readouts later this year.

Dennis Lanfear: Mike, did you have a follow-on question?

Michael Thomas Nedelcovych: Sure. I have another on Loqtorzi, if that is okay. I am just curious, given that you have a better sense of seasonality, do you still think Loqtorzi can get to roughly $30 million to $35 million in quarterly sales in 2027, or might it take a bit more than that?

Dennis Lanfear: We are confident in doing so. In my prepared remarks, I reiterated guidance on three key issues with respect to the revenues: first, reaching $15 million per quarter sometime this year in 2026; second, reaching $30 million to $35 million per quarter sometime in 2027; and third, reaching what would be an annualized $175 million per year, which is about $44 million per quarter, sometime in 2028. I think that our data purchases and our knowledge now of the therapeutic area give us confidence we will be able to do that.

Michael Thomas Nedelcovych: Great. Sorry I missed that. Appreciate the update. Thanks.

Operator: Thank you. We will take our next question. The question comes from Analyst from H.C. Wainwright. Please go ahead.

Analyst: Sorry. Can you hear me?

Dennis Lanfear: Yes. Hello? Can you hear me? Hi, Doug.

Rosh Dias: Yes, Doug. Hello.

Analyst: Sorry about that, I had you on mute at first. Thanks for taking the questions. Just on the Loqtorzi issue in terms of the impact from storms, was this something that affected largely new patient starts, or was it simply a function of patients on ongoing therapy? And should we think of this as purely deferred revenue that eventually should catch up for the rest of the year?

Dennis Lanfear: Sameer, do you want to take that one?

Sameer Goregaoker: Thank you, Doug, for the question. I believe it affected our existing patients. As I mentioned in my prepared remarks, we had more new accounts either starting or restarting new patients than we had in the past, so our new patient growth seems robust. For existing patients, because of seasonality, insurance changes, plus the weather, there were some hiccups in ongoing treatment, so that is where we lost some cycles. I do not think we are going to get those cycles back. If you are 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. But again, that is Q1.

We are excited about the new patient starts continuing on track and our ability to drive demand growth for the rest of this year.

Dennis Lanfear: Thanks, Sameer.

Bryan J. McMichael: Thank you, Doug.

Analyst: Thanks. Can I jump in with a follow-up, Denny?

Bryan J. McMichael: Sure.

Analyst: On TAGMO, we have a significant number of readouts beginning in the middle part of the year and into the second half. When you think about where you are from a balance sheet, are you able to—assuming you succeed with these studies—continue to prosecute all these opportunities, or is there some prioritization that might need to happen?

Dennis Lanfear: I would direct you back to my prepared remarks at the beginning of the call. We are certainly funded through 2026 and all of 2027 for turning over all the data cards. If we have an unfunded clinical trial or we have something that we believe is worthwhile, we take it to our investors. 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 was not funded, as well as the prostate study with J&J—both of which, I think you would agree, are very worthwhile. We do not foresee any additional trials right now.

We have done a very good job with a very broad development program across tagmoketug and a very highly focused program with respect to casdozoketug. So I think we are set.

Analyst: Okay. Great. Thank you.

Rosh Dias: Thank you, Doug.

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

Dennis Lanfear: 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 will see you at Jefferies where we will be presenting, and we will also be at ASCO. Thank you. Bye-bye.

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

Unknown Speaker: Goodbye.