Q2 2025 Coherus BioSciences Inc Earnings Call

Speaker #3: Thank you for standing by. My name is Jordan, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Coherus Oncology Earnings Conference call.

Speaker #3: All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If ou'd like to ask a estion during this time, simply press star followed the number one on your telephone keypad.

Speaker #3: If ou'd like to withdraw your estion, press star one again. Thank you. I'd now like to turn the conference over to Jodi Sievers, Head of Investor Relations for Coherus Oncology.

Speaker #3: You may begin.

Speaker #4: Thank you, Jordan. Good afternoon, and welcome to Coherus Oncology's second quarter 2025 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Bryan McMichael, Chief Financial Officer; Dr. Rosh Dias, Chief Medical Officer; Dr. Theresa Lavallee, Chief Scientific Officer; Chief Scientific and Development Officer; Sameer Goregaoker, Executive Vice President, Commercial; Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus's current expectations about future events.

Speaker #4: Actual results may vary significantly, and we undertake no duty to update or revise any forward-looking statement. Please see the press release that we issued today and our quarterly report on Form 10Q for more information on risks and uncertainties.

Speaker #4: And now, I'll turn the call over to Denny.

Speaker #5: Oh, thank you, Jodi, and welcome all. In Q2, 2025, we completed our strategic repositioning and renamed our company Coherus Oncology, to better reflect our mission.

Speaker #5: Today, in addition to reviewing the progress we made in growing our commercial revenue and advancing our clinical oncology programs, the head of key data readouts and the first half of 26, I want to take the opportunity to introduce you to our new company and highlight what sets us apart.

Speaker #5: Today, I'll be focusing for you on three main points of Coherus Oncology. First, who we are as a company in terms of science, products, and mission.

Speaker #5: Second, what we are doing clinically and strategically to advance that mission through combinations of products in collaborations with partners. And third, why our proven track record in deals and partnerships and in development.

Speaker #5: It gives us confidence we will successfully execute globally on our plans of creating significant value for our US-focused business. First, let's talk about who we are.

Speaker #5: Coherus Oncology is a commercial stage innovative company built on deep science. Focused on developing cutting-edge cancer therapies, our goal is to deliver a step change in survival for cancer patients using new generation first-in-class and best-in-class therapeutics.

Speaker #5: Our science is reading through to clinical results, and patient benefit. For example, our next generation PD-1 inhibitor, Tirapelimab, has a unique FG loop binding site and significantly higher potency compared to standard-of-care PD-1s.

Speaker #5: And this has translated to demonstrated efficacy in low PD-L1 cancers. While other standard-of-care PD-1 treatments have lost approval for low PD-L1 esophageal cancer in the US, Tirapelimab has been approved across all PD-L1 levels for first-line esophageal in the EU, validating its genuine mechanistic and clinical differentiation.

Speaker #5: Approved for use in recurrent or metastatic nasopharyngeal cancer, lactose, which is the brand name for Tirapelimab, demonstrated a pivotal study of compelling 37% improvement in overall survival versus standard-of-care.

Speaker #5: Earning top ranking on NCCN guidelines. We translated this to increase adoption by physicians and patients fueling commercial growth. Lactose net revenue in the second quarter grew 36% over Q1 2025, to $10 million.

Speaker #5: Nasopharyngeal cancer represents 150 to 200 million dollar market opportunity for us. However, the larger commercial case for lactose lies in combination therapy with both our pipeline product candidates as well as other companies' products.

Speaker #5: In the latter case, we supply the drug, but do not fund the trials. Potentially expanding the lactose label very cost-effectively. Now, let me move to the development strategy for the pipeline assets for just a moment.

Speaker #5: The step change in cancer patient survival we seek requires multiple mechanisms of action working in concert to attack tumors. Our pipeline assets have complementary MOAs to lactose, and we are actively advancing combination studies across prioritized indications.

Speaker #5: Collaborations are key to combinations as we don't want to overlook any potential significant therapeutic benefit in combining any of our assets, with another company's approved or experimental agents.

Speaker #5: Thus, developing strategic partnerships is an integral part of our overarching development strategy, and dovetails with our efforts to license the pipeline XUS, as I will describe later.

Speaker #5: This results in a very capital-efficient indication expansion strategy for our products, and sets us apart from other companies as we do not constrain ourselves to just using our own portfolio.

Speaker #5: Let me now briefly review each of our pipeline product candidates. First, CHS 114, our anti-CCR8 T-Reg depletor. And then, Casdoso Keto, our anti-IL-27 antagonist.

Speaker #5: In terms first, how they were scientifically brought forward, second, why they are so promising, and third, the rationale for the development path we've chosen.

Speaker #5: And then, Dr. Dias, our chief medical officer, will review the ongoing studies and the upcoming data readouts expected in the first half of 26.

Speaker #5: First, CHS 114, our potential best-in-class CCR8 T-Reg depletor. Now, normally, T-regulatory cells act as brakes on the body's immune response. Preventing autoimmune disease. In cancer, particularly with solid tumors, T-Regs help tumors evade the mune system, allowing them to grow unchecked.

Speaker #5: While the existence and role of T-Regs was known years before, in 2016, researchers found that T-Reg cells and the tumor microenvironment had a unique receptor, CCR8, on their surface.

Speaker #5: This sparked rush to create antibodies that target CCR8, with the objective to eliminate these specific T-Regs and not others. And boost the immune system's response against tumors.

Speaker #5: This was viewed as a potential major breakthrough goal in the years-long battle against cancer. CHS 114 was developed with great care to specifically target only CCR8.

Speaker #5: Ensuring it doesn't bind to other receptors outside the tumor microenvironment, which would cause side effects. And limit its use. However, CCR8 is a GPCR receptor.

Speaker #5: And targeting such receptors is notoriously difficult. As they're so little protein on the cell's surface for binding, making antibody development very challenging. The development process for CHS 114 was rigorous.

Speaker #5: And candidate agents were screened against over 5,200 known off-target sites to ensure selectivity. The result of this effort is the only known anti-CCR8 T-Reg depleting agent with no off-target binding.

Speaker #5: Which may avoid unnecessary toxicity. Two key points here. First, some CCR8 competitors are encountering off-target binding in their development programs. And some are finding dose-limiting toxicities.

Speaker #5: Secondly, CHS 114's high selectivity makes it potentially best-in-class, giving us competitive advantage in terms of development timing and market entry. It's important to note that we are the only independent US biotech developing a CCR8.

Speaker #5: And the US FDA approval is highly valuable, XUS, in s of partnering. Which is a key focus for us. We are working efficiently and aggressively, of course, to bring CHS 114 to market for key indications in the US as quickly as possible.

Speaker #5: And we making good progress. With our head-and-neck trial, Coherus Oncology is the first US company to demonstrate that anti-CCR8 treatment can deplete T-Regs in tumors.

Speaker #5: 114 treatment also led to increased CD8-positive T-cell infiltration in the head-and-neck cancer patient tumors. I would also note that in combination with lactose, in this same study, we saw a partial response and significant reduction of target and non-target lesions, in a fourth-line patient.

Speaker #5: Of course, given the promise of the mechanism of action, targeting CCR8 has become very competitive. However, the upside is that this class of treatments is gaining broad validation across various tumors and settings, particularly in combination with a PD-1.

Speaker #5: Importantly, given the MOA, there is also the potential for broad combinability of anti-CCR8s across other efficacious modalities. Such T-cell engagers ADCs and so on.

Speaker #5: This is the subject of our partnering efforts, both in the US and XUS. We currently have clinical studies in head-and-neck, gastric, esophageal cancer, which we will review directly.

Speaker #5: However, I wish to point out that Dr. Alexander Radinski, Chairman of Immunology at Memorial Sloan Kettering, and key member of our Coherus Oncology Scientific Advisory Board, recently published two important preclinical papers characterizing the immune suppressive role of T-Regs in colorectal cancer.

Speaker #5: An area of burgeoning unmet need. We are currently developing clinical plans to address this increasingly common disease. Affecting younger patients. As recently reported by the Journal of American Medical Association.

Speaker #5: We believe that in 2026, anti-CCR8s will start to realize their therapeutic promise. And become a new treatment backbone used broadly across many solid tumor types.

Speaker #5: Let me now refresh you on Casdoso Keto, a unique first-in-class opportunity in our pipeline. Casdoso Keto is the only known anti-IL-27 treatment currently in development.

Speaker #5: And IL-27 plays a key role in the immune responses within barrier tissues. Such as liver and lung. It is well known that cytokines in the mune system are tightly linked to cancer.

Speaker #5: And it been demonstrated that IL-27's role in mediating the immune response is the basis for its mechanism of action. Mechanistically, within the tumor microenvironment, IL-27 facilitates tumor growth in three ways.

Speaker #5: First, by inducing checkpoint expression, such as PD-1's LAG3s and others on the surface of T-cells. Inhibiting the mune response. Secondly, by reducing pro-inflammatory cytokines, weakening the immune response and lastly, affecting natural killer cells.

Speaker #5: Preventing them from attacking tumors. This makes IL-27 a novel and distinctive target, with a regional modulatory mechanism that is synergistic with checkpoints. Attacking immune resistance from a complementary direction.

Speaker #5: What's important for you to think about here is that the translation of the data from our model systems to the human clinical trials is impressive.

Speaker #5: Giving us a clear path forward for development. Across preclinical mouse models, IL-27 was shown to have an important role in turning off T-cells and NK cells in lung and liver.

Speaker #5: These are the two key tissue types we have chosen to investigate for therapeutic effect. And compelling efficacy has been demonstrated in first-line liver cancer patients.

Speaker #5: As previously disclosed. Coherus Oncology has global rights to Casdoso Keto. And hepatocellular carcinoma is a global disease. With particular incidence in Asia and other regions, including Europe and Mina.

Speaker #5: This makes the XUS licensing efforts of Casdoso Keto a priority for us. And we believe the success of such efforts will follow from strong clinical data.

Speaker #5: Such partnering across regions can be expected to provide three things. First, validation of the value of our pipeline. Second, non-dilutive financing for ongoing clinical development.

Speaker #5: And third, cost offsets for larger pivotal clinical trials to come later. Dr. Dias will now provide clinical development rationale and update, letting you know what you can expect next year as the data reads out.

Speaker #5: Then, Sameer Goregaoker, our executive vice president of commercial, will provide NPC market color as well as a summary of the large market opportunity of the pipeline product candidates.

Speaker #5: Rush?

Speaker #6: Thank you, Denny, and good afternoon, everyone. I'll start with a review of our clinical program for CHS 114 before moving on to Casdoso Keto.

Speaker #6: Given the biology, DHS 114 has potential utility in multiple areas, and we have active trials across several tumor types. Firstly, in second-line head-and-neck squamous cell carcinoma, where the rationale for exploration is several-fold.

Speaker #6: First, this is a tumor type that is well supported by high-target expression in terms of the prevalence and density of CCR8-positive T-Regs in the tumor.

Speaker #6: Additionally, this is an indication synergistic with the current indication for lactose in NPC, a subtype of head-and-neck cancer. And furthermore, clinically, we've very encouraged by the confirmed partial response demonstrated earlier in the head-and-neck program.

Speaker #6: In a very late-line patient, previously refractory to prior PD-1 inhibition, with this data being presented at AACR a few months o, and which firmly supports continued development in head-and-neck.

Speaker #6: Our head-and-neck squamous cell trial explores two biologically active doses of CHS 114 in combination with Tirapelimab in the second-line setting, which is currently an area of very high unmet medical need with the goal of declaring a dose for continued development, whilst at the same time developing further efficacy and safety data and aiming to address FDA's project optimus.

Speaker #6: This trial is active and ongoing, and we remain on track to develop efficacy to deliver efficacy and safety data in the first half of 2026 previously communicated.

Speaker #6: The second priority tumor type for CHS 114 is second-line gastric cancer, which again is supported by the biology and has demonstrated proof of principle of the CCR8 class in combination with Tirapelimab specifically as communicated in data presented at AFCA24.

Speaker #6: The approach here is to include patients with gastric, GEJ, and esophageal adenocarcinoma and again to explore two biologically active doses in combination with Tirapelimab in 40 second-line patients.

Speaker #6: This trial is active and ongoing in US and Asia-Pacific sites, and we anticipate safety and efficacy results over the course of next year as previously discussed.

Speaker #6: The third tumor type we're ursuing is in esophageal squamous cell carcinoma, where we're looking at both a first-line and a second-line population. As a reminder, lactose has demonstrated activity irrespective of PD-L1 levels in the first-line setting.

Speaker #6: And we are exploring Tori-114 combination with chemo in first-line ESCC. Concurrently, we're also pursuing second-line esophageal squamous cell with the Tori-114 combination as a faster market strategy as the current standard of care constitutes a large area of unmet medical need.

Speaker #6: Both cohorts are active and ongoing in the US and Asia-Pacific sites, and we anticipate safety and efficacy results over the course of next year.

Speaker #6: Casdoso Keto, our first-in-class IL-27 targeting antibody, is progressing in our first-line hepatocellular carcinoma study. As a reminder, the current ongoing phase two study is a three-arm, 72-patient study exploring two biologically active doses of Casdoso in combination with Tirapelimab and bevacizumab, compared to Tori-bevalone, which, in addition to generating further efficacy and safety data, aims to address FDA's project optimus dose optimization requirement, whilst at the same time addressing contribution of components as we move through the development pathway.

Speaker #6: As a reminder, this ongoing study builds upon the very encouraging data presented at AFCAGI in January this year, demonstrating a 38% overall response rate and a 17% complete response rate with addition of Casdoso to the current standard of care at Tizo and Bev, where historically, the overall response rate has been around 30%, and the complete response rate around 8%.

Speaker #6: In our study, we've shown a deepening of responses over time, and responses irrespective of viral or non-viral etiology. This trial is currently active and ongoing in the US and the Asia-Pacific region, and we anticipate safety and efficacy data in first half of '26, as previously communicated.

Speaker #6: Finally, building upon the monotherapy activity previously demonstrated in late-line non-small cell lung cancer with squamous histology, Casdoso is also under development in squamous non-small cell.

Speaker #6: With a randomized phase two study sponsored by a prominent investigational group currently in the planning stages and expected to commence next year. With that, I will hand things over to Sameer.

Speaker #6: Sameer?

Speaker #7: Thank you, Rush. Q2 marked the first quarter when we operated as a dedicated innovative oncology company. This enabled us to maintain a singular focus on educating physicians on lactose, as a differentiated and highly efficacious PD-1 for NPC patients.

Speaker #7: Our goal is to establish lactose as the standard of care and preferred regimen for all eligible NPC patients. We are happy to report strong progress towards that goal.

Speaker #7: Net revenue in Q2 was $10 million, a 36% increase quarter over quarter, and a 65% increase year over year. Q2 performance was driven primarily by strong demand from new patients and some positive impact from wholesaler inventory rebuild following a drawdown in Q1.

Speaker #7: Our execution in Q2 was driven by a lactose-only sales force supplemented by robust digital marketing efforts. We were focused on educating physicians on the updated NCCN guidelines, and we are pleased with the reactions that we have seen.

Speaker #7: Over 90% of the 33 NCCN institutions have now used lactose in their NPC patients. The number of new purchasing accounts has grown by 20%, and indicator of the increasing breadth of use.

Speaker #7: And we saw a 22% increase in accounts using lactose in a subsequent patient after initial trial indicating greater depth of use. Among academic KOLs and head-and-neck specialists, we have seen a significant move towards adopting lactose in both the first-line and the second-line plus setting.

Speaker #7: This adoption comes at the expense of off-label IOs and chemo-only use both of which are non-preferred in updated NCCN guidelines. Feedback from KOLs has been very positive, and we hear a strong preference for the brand over non-preferred regimens.

Speaker #7: While we are pleased with the results of our promotional efforts, significant growth opportunity remains primarily in the community setting. Over half of the addressable patients are managed in this segment.

Speaker #7: But adoption is generally slower in community oncology than in the academic centers. There are more than three times as many target community oncologists versus academic HCPs but these physicians typically see a much smaller number of NPC patients each year.

Speaker #7: As a result, advances in NPC treatment and NCCN guidelines are not top of mind for these physicians. So in second half 2025, we are using a combination of sales force, digital, and data to unlock the community opportunity.

Speaker #7: First, we are launching a refresh messaging platform this month that clearly articulates a strong efficacy and superiority versus chemo only. Second, we're developing highly engaging KOL-driven digital content to help educate community oncologists.

Speaker #7: And third, we're doubling down on our investment in real-time data to drive intelligent targeting of HCPs and patients at the time of diagnosis. With a strong focus on commercial execution, we expect that lactose revenue will follow typical rare disease dynamics.

Speaker #7: With the steady ramp fueled by new patient acquisition and broad adoption in the community setting. I'd like to end this session by saying that we remain on track to achieve our 2025 revenue goals of between $40 and $50 million.

Speaker #7: And to achieve a dominant share in NPC market, which is estimated to be in the range of $150 to $200 million. While lactose will fuel our near-term growth, we are excited about the impressive commercial potential of our two pipeline assets.

Speaker #7: A key point I want to note at this point is that all of our clinical trials for both CHS 114 and Casdoso are paired with lactose.

Speaker #7: As a result, each new indication approval would represent a label expansion for lactose and we would realize revenues from both the novel agent and lactose.

Speaker #7: Through our lactose commercialization efforts, we continue to build a best-in-class oncology organization with proven launch capabilities. At the time of potential approval of our pipeline indications, we will be well-positioned to benefit from this commercial expertise as well as our relationships across the oncology community.

Speaker #7: For Casdoso, HCC represents a US market opportunity of about $4 billion and the potential for significant improvement in patient care. If the data readouts continue to be positive for Casdoso, the commercial organization will be well-positioned to support the potential for a new standard of care for patients in this area of high unmet medical need.

Speaker #7: For CHS 114, as Denny mentioned, we believe we may have a best-in-class non-partnered US asset. Second-line head-and-neck cancer for this molecule is a market of about $4.5 billion.

Speaker #7: While second-line gastric cancer represents $3.5 billion, and esophageal cancer comes in at just under $1 ion. In isolation, any of these potential indications for our pipeline assets represent a significantly large US commercial opportunity.

Speaker #7: With the potential for multiple indications compounded by incremental XUS markets, we are very excited about our novative immuno-oncology portfolio. While we remain in the near-term focused on maximizing the NPC indication, our commercial organization stands ready to support the next phase of our growth in the coming years.

Speaker #7: With that, I'll now pass the call to our CFO, Bryan McMichael.

Speaker #8: Thank you, Sameer, and good afternoon, everyone. Today, I will limit my discussion to key financial updates and refer you to our earnings press release for the second quarter and year-to-date 2025 figures and detailed results.

Speaker #8: I'm happy to report that Coherus has made strong progress on its operational and financial transition, fully consistent with our plans outlined in last quarter's call.

Speaker #8: Following the close of the divestiture in April, we used a portion of the $483 million in upfront cash proceeds to complete the payoff of substantially all the $230 million convertible notes as well as buy down the Udenica royalty obligation.

Speaker #8: We ended Q2 with $238 million in cash and investments, and we project sufficient cash to provide runway through 2026 beyond key data readouts. Cash burn continues to moderate as per plan, quarter to quarter in 2025, as we wind the down the transition service agreement activities associated with the divestiture and settle pre-close remaining liabilities.

Speaker #8: A majority of the $97 million in accrued rebates fees and reserves of the balance sheet down from $148 million last year will be settled over the coming quarters through 2025 and 2026.

Speaker #8: I'm also pleased to report in Q2 we achieved additional progress on our managing of our costs and cost structure and expenditures. We now expect to save approximately $30 million on an annualized basis from from Q2 headcount reductions up from $25 million communicated in Q1.

Speaker #8: This includes the employees' transition in the divestiture and other reductions initiated during Q2. We remain on track per plan to be at $150 FTEs or less by year-end, which will yield an additional approximate $5 million in annualized savings over the P1 guidance.

Speaker #8: Existing--excuse me. Exiting the legacy business has allowed us to simplify our operations and reduce operating costs, particularly as they relate to supply chain and commercial activities.

Speaker #8: Net of non-reimbursed transition service costs SG&A incurred solely for Coherus programs and expenses for the full year 2025 is projected to be between $90 and $100 million.

Speaker #8: R&D expenses will be a function of data readouts in our ongoing portfolio prioritization process, and we'll be able to provide more detail on that later in the year.

Speaker #8: With that, I'll hand it to Denny.

Speaker #9: Thank you, Bryan. Let me close with a few key points that reflect the strength of our company. Our focus on our drugs, our data, and our deals with effective execution makes it happen.

Speaker #9: The science behind our drugs is first rate, next generation, first-in-class, and arguably best-in-class addressing very large markets. Our data, our science is already and continues to translate, strong clinical data step change survival benefit the patients.

Speaker #9: Strong clinical execution is keeping us on track to a turnover key data cards in the first half of next year, meeting your expectations. And then there's our als.

Speaker #9: Excellent deal execution defined our strategic transformation into a focused innovative oncology company. And it will now unlock significant pipeline value through XUS licensing deals which will do three things over the next six 12 and 18 months.

Speaker #9: First, validate our science and our products. Secondly, monetize our global rights with upfronts. And third, offset our global development costs for the future. And in the US, we will see collaborations that expand our labels cost-efficiently through combinations with development partners.

Speaker #9: Strong execution across all three of these dimensions will deliver value to shareholders and has enabled by world-class advisors and board members working integrally with our team.

Speaker #9: We expect our strong balance sheet to support operations through '26. Well beyond our key clinical catalysts. Operator, we're appy now for you to open the line for questions.

Speaker #10: Just as a reminder, if you'd like to ask a question, press star, followed by one on your telephone keypad. Just one moment while we compile the roster.

Speaker #10: Your first question comes from the line of Bryan Chang from JP Morgan. Your line is live.

Speaker #11: Hey, guys. Thanks for taking a question this afternoon. Maybe we can start off with the pipeline. As you think through your CCRA program, your 114 program, and your overall approach in the near term, can you just talk about how important it is to identify a partner, perhaps regional partners, to accelerate some of the progress that you have made in the near term?

Speaker #11: And if there is interest in that, when do you think it'll be a od time to look for a ner here? Thanks. And then we have a follow-up.

Speaker #12: Yeah. Thanks, Bryan, for that. First of all, Rush, you want to recap for us when we will see the data cards turned over for 114?

Speaker #11: Yeah, absolutely. Thanks, Bryan, for the estion. So we will for both molecules, actually, we anticipate seeing both efficacy and safety data in the first half of next year.

Speaker #11: But specifically for CHS 114, for our head-and-neck program, we again will see efficacy and safety data in the first half of the year, building, of course, on the data sets that I've the very encouraging data sets actually that I've previously communicated.

Speaker #11: For gastric and esophageal, for 114, we anticipate safety in the first half of the year. And then efficacy the second half of the year.

Speaker #12: Yeah. Thanks. So Bryan, we're funded through those studies. With the product, but as I indicated in my prepared remarks, we expect partners to work collaboratively with us and help us offset these development costs.

Speaker #12: And I think the issue of the timing really strikes also to the development of others. Teresa, you want to add a ment?

Speaker #2: Yeah. Thanks, Bryan. I think there's a couple of key data sets as we look. As we rush outlined that we'll be getting to a recommended phase two dose.

Speaker #2: So that simplifies the development, and I think makes it more attractive. Our partners and other regional areas additionally, what we showed at AACR and besides just T-Reg depletion and clinical response, we showed a marked infiltration of CD8 T-cells.

Speaker #2: Which really has caught the attention of several folks because that clearly lends itself to combinations with other modalities outside of Tirapelimab, such as T-cell engagers.

Speaker #2: And so I think what we're having is active conversations with people to look for the right partner both to test other tumor types as well as other combinations.

Speaker #2: And then folks that are prioritized are tumor types where we expect to see efficacy and look at other regions. So all of those conversations are ongoing, but I think it would be really important for us to find a partner that can run with us and not complicate the speed at which we want to move this program.

Speaker #12: Yeah. And I would add two other points for you, Bryan. First of all, the CCRA T-Reg depletor class is under vigorous development, as you know, globally.

Speaker #12: And there are data sets being put forward at various meetings. And we've expected that. And we would expect those data sets sometime over the next 6 to 12 months, say, to accelerate.

Speaker #12: We think 2026 will be the year that CCRA has come to the fore. The second point is, Teresa indicated, is that we're very open-minded with respect to combining our CCRA with other drugs.

Speaker #12: We're not constraining ourselves just to our own portfolio. We think there's broad applicability for the mechanism of action here and we intend to take advantage of that.

Speaker #11: Great. And then maybe just one quick one on lactose. Just based on the trajectory and also some of the dynamics you're aring from doctors, how confident are you on your path towards the 152, 200 million goal for the franchise?

Speaker #11: Are there any indicators that you're now seeing that get us that you confident in yourself moving toward that goal? Thanks.

Speaker #12: Thanks, Bryan. Sameer, you want to handle that?

Speaker #7: Yeah. Thank you, Bryan. First of all, let me just kind of answer that. So we feel pretty confident. We're expect that we'll get to peak revenues by 2028.

Speaker #7: And just one piece of anecdotal evidence that gives us confidence. After the NCCN guidelines got updated, we saw a pretty strong uptake in the academic setting.

Speaker #7: In the hospitals and the head-and-neck specialists, they're the ones who are waiting for the guidelines updates. And once guidelines got updated, we communicated the data to them.

Speaker #7: They really jumped on the bandwagon. So what we need to do now is do the same thing and educate the community on our data sets.

Speaker #7: So we feel pretty confident, Bryan.

Speaker #12: Thanks, Bryan.

Speaker #10: Your next question comes from the line of Michael Nadalkovich. From TV Cow. And your line is live.

Speaker #13: Hi. Thank you for the question. I have two. My first question is on the anti-CCR8 program. You mentioned competitor readouts that could serve as sort of stalking horses for your molecule.

Speaker #13: Are ou aware of any, as you survey the competitive landscape, that would that you would consider proof of concept for the mechanism? So perhaps randomized trial?

Speaker #13: That's my first question. And then my second question is actually on the competitive landscape for your anti-IL-27. I know you have the potential here to be first in class.

Speaker #13: Have you seen any follow-on molecule any follow-on programs from competitors? Are there other anti-IL-27 molecules in development that perhaps we don't know about? Thanks.

Speaker #12: Thank you, Michael. Those were thoughtful and very pertinent questions. Teresa, do you want to address the competitive profile for both of the two molecules, CCR8 and Casdoso?

Speaker #2: Yeah. I'll start with the second one first for Casdoso key type. We are not aware of anyone else going into clinical development with an IL-27 antagonist.

Speaker #2: We have garnered a lot of interest from partners with the HCC CR rate. So continue those discussions. For the CCR8, what I find compelling is every time we see a data card turned over, we're seeing efficacy.

Speaker #2: We saw at ASCO this year that Lenova presented data in pancreatic cancer showing a 22% overall response rate, I believe, in combination with Tirapelimab, which is quite impressive and refractory pancreatic cancer.

Speaker #2: Additionally, Shinogi with their IGG1 wild type antibody. So a less potent molecule than ours. So to complete response and a PR in colorectal cancer.

Speaker #2: A tumor type that really MSS colorectal cancer has been underserved. So, as we see each data readout come, it's looking quite interesting. The only randomized study that has been reported publicly is Lenova.

Speaker #2: Advancing in MSI high colorectal cancer. So we actively troll ClinicalTrials.gov and the reporting of these molecules, as we've heard a lot of buzz in the community and expect to see updates in the next year from other folks, as well as our own programs.

Speaker #12: Yeah. I just dovetail on Teresa's remarks. Michael, there is, of course, robust development activity across a number of big pharmas. No one's talking very much right .

Speaker #12: But we suspect over the next 6 or 12 months there's going to be quite a bit of data come to the fore, certainly maybe next year by ASCO.

Speaker #13: Great. Thank you so much.

Speaker #12: Thank ou.

Speaker #10: Your next question comes from the line of Colleen Husi from Baird. Your line is live.

Speaker #2: Great. Good afternoon. Thanks for taking our questions. A few from us. You spoke about on the commercial side making some investments into the community that's largely untapped right now.

Speaker #2: Can you just walk us through those and when you expect those might bear out into the sales trajectory? And then we have a couple of -ups, please.

Speaker #7: So Sameer, ou want to handle that?

Speaker #12: Yeah. Yeah. Thank you, Colleen. So the community, one of the dynamics of the community is that there's we have to target at least three times as many physicians in the community as the academic setting.

Speaker #12: And the number of patients in the community is very dispersed. So each physician sees maybe one or two patients a year. So but at the same time, we can't ignore the community because half the patients are in the community.

Speaker #12: So what's going to happen is we're focusing now refocusing our efforts on the community, both from the sales force standpoint, the digital standpoint, and we're also purchasing a lot of data.

Speaker #12: To identify the physicians with the patients at the time of diagnosis. So that whole multi-pronged approach is underway. But I think because of those dynamics, the time for us to really get to peak sale is going to be about those three to four years because you know making a difference in the community is going to be an ongoing process.

Speaker #2: Great. That's pful. Thank you.

Speaker #12: Did you have a long question, Colleen?

Speaker #2: Yep. I know historically you and you spoke to you out-licensed lactose in a capital-efficient way to potentially expand the indications there. Is there thing on the horizon from any partners we should be aware of in terms of potential data readouts?

Speaker #2: And then on the strategy, you know what sort of deals do you think you'd prioritize for lactose licensing in the URE?

Speaker #12: I'll handle the first one, and I'll let Teresa handle the second one. To be clear, we have not out-licensed lactose. What we have done is enter into collaborative strategic arrangements whereby we supply lactose for others' clinical trials.

Speaker #12: The strategy being that as they develop those products, we will eventually get a label that that we can promote against. And we do that.

Speaker #12: We just the only cost to us really is just supply of the drug, which is not very significant. So this is very this is a very cost-effective.

Speaker #2: Yeah. And the last call, we talked about storm therapeutics. Having those steady ongoing and enrolling in both head-and-neck cancer and lung cancer, two tumor types that complement the data sets we have in hand for Tori I mean, I can't speak for how they would disclose data, but knowing that team I would anticipate some update next year.

Speaker #2: The other studies are on track to start. And additionally, we would look towards more announcements later this year. We're now only announcing them when first patient is dosed.

Speaker #2: So we don't have to wait a long time for data. So hopefully next year we'll see some data readouts.

Speaker #12: The other point I would make pursuant to your question is a , though, that Teresa makes frequently, is that if you are a company developing a new therapeutic, you want to make sure that you have a highly active next-generation you know PD-1.

Speaker #12: If you're not constrained to using you ow the standard of care, which will go biosimilar and you know a few years in 2020 or whatever, so the interest that we have had in terms of partnering and co-development, I think, driven from that is lactose's outstanding efficacy and safety profile.

Speaker #2: Great. That's really helpful. And then last one for us. Just on the randomized phase two for Casdoso, Tori-Bev, and front-line HCC, can you just comment on how enrollment is going there?

Speaker #12: Rush, how is enrollment going?

Speaker #11: Yeah. Thanks for the question, Colleen. So yeah. So recruitment's going well. We are recruiting in the US and in the Far East. So these are active trials that, again, we're on track to report data for in the first half of next year, both for efficacy and safety.

Speaker #11: Just recall, though, that with HCC in particular, responses can take a little bit of time to mature and become more kind of deeper as well, which is what we saw in our earlier trial.

Speaker #11: So bear that in mind as well. But we're on track with improvement.

Speaker #2: Great. Thanks for taking our estions.

Speaker #12: Thanks, Colleen.

Speaker #10: Your next question comes from the line of Lee Chen from HC Wainwright. Your line is live.

Speaker #14: Hi. This is Lee Chen for Doc Tow. Thanks for taking our questions and congratulations on the quarter. So maybe to start with, I'm curious to know if you still follow the first-line HCC patients treated with the triplet of Caso-Atizo and Bev.

Speaker #14: And if there's any insight into the durability there, or maybe when should we expect those data to be presented? And I have a follow-up.

Speaker #11: So the data set that you refer to is with the Atizo triplet data. And we did present the final data in January of this year at ASCOGI.

Speaker #11: And that was the data set that referred to in my prepared remarks with an overall response rate of 38%, a CR rate of 17%, which compares obviously favorably with current benchmarks.

Speaker #11: So that trial is the Atizo trial. The trial that we're recording that's ongoing right now, and that we will report out next year, early next year, initial in terms of initial data is the Tirapelimab Casdoso.

Speaker #11: Bevacizumab triplet, right? So we've switched obviously to our own PD-1. And that's the 17-patient study that I described.

Speaker #14: I see. So I guess I'm asking for PSS and OS data from the initial triplet results. So it sounds like you 't plan to report?

Speaker #11: Yeah. So that Atizo data was reported in January. And in terms of durability, a couple of things I'll mention. Number one, there was a deepening of response over time.

Speaker #11: And also, obviously, an increase in response rate. And secondly, for those responses, there was durability. The majority of those responses were six months or more.

Speaker #14: But the PSS is reported as 8.99.

Speaker #11: Right. Exactly.

Speaker #14: So higher than the IMBRA of 150 and the OS data. It's still maturing. Great. Thanks for the arification. And my second question is regarding the next phase in the next phase of development in first-line SCC, how do you think the comparator arms for the phase three?

Speaker #14: Do ou think the data in the first half '26 will be enough for decision-making?

Speaker #11: Well, I think we'll so we'll have initial data in terms of efficacy and safety, as I've ioned, in the first half of the year.

Speaker #11: But again, in HCC, it can take a little bit of time for the data to mature, meaning it can take a little bit of time for the data the full effect to be realized, right, in terms of depth of response.

Speaker #11: So once we have that, the next stage will we anticipate will be a you ow, a next-stage trial, phase two, phase three. With compared to the current standard of care, the majority of in the majority of countries worldwide, the current standard of care is Atizo, Bev.

Speaker #11: So that's what we anticipate will be the comparator. And again, some of those benchmarks that I mentioned earlier of 38% for us, for overall response rate, compared to 30% for Atizo, Bev.

I I would, I would say unequivocally none. Um, you know there's a failed Phase 2 study. Uh we are the only label pd1 and I and I think that there's a a good appreciation by physicians uh of the power of strong data in our, our data is very very strong for nasal fairing gel cancer. What? And you'll have to remember that biosimilars only get the label for the reference product.

so, it would be

They would not have a label. Yeah, yeah.

But thanks for the question.

Got it, thanks.

Your final question comes from the line of Douglas s from HC Wayne Wright.

Hi, good afternoon. Thanks for taking the questions. Just

Can you hear me?

Yes. Yes, we hear you, Doug.

Hey great. Thanks. Thanks for for for squeezing the end and and I hope I didn't miss it. But um, I did want to um ask about the impact of the guidelines. I think you touched on sort of the difference between the the centers of excellence as well as in the community setting. And I'm just curious, um, are are the guidelines sort of permeating or the impact of the guidelines, permeating out into the community and it's just taking a little bit longer. Um or is it really? They are not necessary.

Necessarily following them as closely as what you're seeing in the in the major academic centers.

So they don't follow the guidelines. They only see a very small number of patients every year, and they just go by what they remember from last time. It takes a while for them to head and neck basically, or native financial carcinoma is not top of mind for them, because our job is to keep detailing them and educating them until those guidelines get really established in their practice. So it's going to be a process, but we're really focused on executing that process. We believe that we will make an impact in the community as well.

Okay, great. Thank you so much and congrats on the progress.

Thanks d.

There are no questions that concludes the Q&A session. I'll turn the call back over to Denny lansere for closing remarks.

Thank you, thank you all for joining us on our call. I, I think, as you can see, in today's call, we really hit our stride with regards to the execution, both clinically and commercially and otherwise, uh, with the company, strong balance sheet. We'll keep us moving through next year while we turn over the data cards. And we look forward to seeing you guys at the Barrett and the hcw conferences, the second week of New York. Thank you.

this concludes today's conference call, you may now disconnect