CHRS - NASDAQ

Coherus Oncology, Inc.

CHRS·NASDAQ

$1.57

+6.8%

HealthcareBiotechnology

Coherus Oncology, Inc., a biopharmaceutical company, researches, develops, and commercializes immunotherapies to treat cancer in the United States. The company develops UDENYCA, a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor; LOQTORZI, a novel next-generation programmed death receptor-1 inhibitor; and Casdozokitug, an investigational recombinant human immunoglobulin isotype (IgG1) monoclonal antibody targeting interleukin 27. It also develops CHS-114, an investigational highly specific human afucosylated IgG1 monoclonal antibody, a chemokine receptor highly expressed on Treg cells in the tumor microenvironment (TME); and CHS-1000, Anti-ILT4 monoclonal antibody for solid tumors. In addition, the company offers GSK4381562, an antibody targeting CD112R to treat tumor cells; YUSIMRY, a biosimilar to Humira for inflammatory diseases characterized by increased production of tumor necrosis factor (TNF) in the body, such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, and ulcerative colitis; and CIMERLI, a Lucentis biosimilar to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. It has a collaboration agreement with Junshi Biosciences for the co-development and commercialization of toripalimab; agreement with Surface and Adimab LLC; license agreements with Bioeq AG and Genentech, Inc. and Surface and Vaccinex, Inc.; and out-licensing agreement with Novartis Institutes for Biomedical Research, Inc. and GlaxoSmithKline Intellectual Property No. 4 Limited. The company was formerly known as Coherus BioSciences, Inc. and changed its name to Coherus Oncology, Inc. in May 2025. The company was incorporated in 2010 and is based in Redwood City, California.

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Market Cap$192.80M

EPS-1.4500

P/E Ratio-1.09

Earnings Date07/30/2026

Earnings Call Transcript

CHRS • 2025 • Q4

Operator

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.

Carrie Graham

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.

Denny Lanfear

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.

Denny Lanfear

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 LOQTOR

Denny Lanfear

Let me provide you with a strategic lens through which to view the company going forward. First, to our financial strategy. LOQTOR

Denny Lanfear

We view LOQTOR

Denny Lanfear

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.

Denny Lanfear

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 LOQTOR

Denny Lanfear

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.

Denny Lanfear

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.

Denny Lanfear

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.

Denny Lanfear

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?

Theresa LaVallee

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.

Theresa LaVallee

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.

Theresa LaVallee

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.

Theresa LaVallee

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.

Theresa LaVallee

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.

Theresa LaVallee

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.

Theresa LaVallee

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?

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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.

Rosh Dias

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?

Sameer Goregaoker

Thank you, Rosh. We're happy to report that LOQTOR

Sameer Goregaoker

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 LOQTOR

Sameer Goregaoker

These guidelines served as a stimulus for LOQTOR

Sameer Goregaoker

In contrast, chemo-only patients live for less than three years. That is a 2.5 years of additional survival benefit for LOQTOR

Sameer Goregaoker

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.

Sameer Goregaoker

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 LOQTOR

Bryan McMichael

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.

Bryan McMichael

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.

Bryan McMichael

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.

Bryan McMichael

Sameer covered in detail LOQTOR

Bryan McMichael

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.

Bryan McMichael

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 LOQTOR

Bryan McMichael

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.

Denny Lanfear

Thank you, Brian. We're pleased with our progress in 2025, having doubled LOQTOR

Operator

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.

Jay Olson

Hey, guys. Congrats on the progress, thank you for taking the questions. We had a couple of questions on LOQTOR

Denny Lanfear

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.

Sameer Goregaoker

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.

Denny Lanfear

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

Sameer Goregaoker

Yeah.

Denny Lanfear

sensitivity of the product?

Sameer Goregaoker

Sure. Regarding promotional sensitivity, LOQTOR

Jay Olson

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

Sameer Goregaoker

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.

Denny Lanfear

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.

Jay Olson

Great. Thank you.

Denny Lanfear

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.

Jay Olson

Super helpful. Thank you for those details.

Denny Lanfear

Thank you, Jay.

Jay Olson

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?

Denny Lanfear

Dr. LaVallee?

Theresa 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.

Jay Olson

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

Theresa LaVallee

Sure. Thank you.

Operator

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

Mike Nedelcovych

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.

Denny Lanfear

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?

Rosh Dias

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?

Rosh Dias

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.

Mike Nedelcovych

Great. Thank you so much.

Denny Lanfear

Thanks.

Operator

Thank you.

Denny Lanfear

Thanks.

Operator

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

Colleen Kusy

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?

Rosh Dias

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.

Rosh Dias

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.

Colleen Kusy

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?

Denny Lanfear

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

Theresa LaVallee

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.

Rosh Dias

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.

Denny Lanfear

Thank-

Colleen Kusy

Great.

Denny Lanfear

Thank you, Colleen.

Colleen Kusy

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.

Denny Lanfear

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.

Colleen Kusy

Great. Thanks for taking the questions.

Denny Lanfear

Thank you, Colleen.

Operator

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.

Brian Cheng

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?

Theresa LaVallee

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.

Brian Cheng

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?

Rosh Dias

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.

Rosh Dias

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.

Denny Lanfear

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.

Brian Cheng

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

Denny Lanfear

Thanks, Brian.

Operator

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.

Douglas Tsao

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.

Douglas Tsao

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.

Denny Lanfear

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.

Denny Lanfear

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.

Denny Lanfear

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.

Denny Lanfear

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 LOQTOR

Douglas Tsao

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 LOQTOR

Sameer Goregaoker

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.

Sameer Goregaoker

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.

Douglas Tsao

Okay, great. Thank you.

Sameer Goregaoker

Thanks.

Denny Lanfear

Thank you, Doug.

Transcript from March 9, 2026