Coherus Oncology, Inc.

a phone keypad. If you'd like to withdraw your question, press star one again. Thank you. I'd now like to turn the conference over to Jody Sievers, Head of Investor Relations for Coherence Oncology. You may begin.

Thank you, Jordan. Good afternoon and welcome to Coherence Oncology second quarter, 2025 earnings conference call. Joining me today to discuss our results are Denny Lanphier, Chief Executive Officer of Coherence, Brian McMichael, Chief Financial Officer, Dr. Rosh Diaz, Chief Medical Officer, Dr. Teresa Lavallee, Chief Scientific Officer, Chief Scientific and Development Officer, Mayor Goria Gauker, Executive Vice President, Commercial. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherence's current expectations about future events. 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. And now I'll turn the call over to Denny.

Oh, thank you, Jody, and welcome all. In Q2, 2025, we completed our strategic repositioning and renamed our company Coherence Oncology to better reflect our mission. Today, in addition to reviewing the progress we made in growing our commercial revenue and advancing our clinical oncology programs ahead of key data readouts in the first half of 26, I wanna take the opportunity to introduce you to our new company and highlight what sets us apart. Today, I'll be focusing for you on three main points of Coherence Oncology. First, who we are as a company in terms of science, products, and mission. Second, what we are doing clinically and strategically to advance that mission through combinations of products and collaborations with partners. And third, why our proven track record in deals and partnerships and in development gives us confidence we will successfully execute globally on our plans, creating significant value for our US-focused business. First, let's talk about who we are. Coherence 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, -in-class, and -in-class therapeutics. Our science is reading through to clinical results and patient benefit. For example, our next-generation PD-1 inhibitor, Torapalemab, has a unique FG-LU binding site and significantly higher potency compared to standard of care PD-1s. 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, Torapalemab has been accrued across all PD-L1 levels for first-line esophageal in the EU, validating its genuine mechanistic and clinical differentiation. Approved for use in recurrent or metastatic nasopharyngeal cancer, Lactorzy, which is the brand name for Torapalemab, demonstrated in a pivotal study at compelling 37% improvement in overall survival versus standard of care, earning top ranking on NCCN guidelines. We translated this to increased adoption by physicians and patients, fueling commercial growth. Lactorzy net revenue in the second quarter grew 36% over Q1 2025 to $10 million. Nesopharyngeal cancer represents $150 to $200 million market opportunity for us. However, the larger commercial case for Lactorzy lies in combination therapy with both our own pipeline product candidates as well as other companies' products. In the latter case, we supply the drug, but do not fund the trials, potentially expanding the Lactorzy label very cost-effectively. Now let me move on to the development strategy for the pipeline assets for just a moment. The step change in cancer patient survival we seek requires multiple mechanism of action working in concert to attack tumors. Our pipeline assets have complementary MOAs to Lactorzy, and we are actively advancing combination studies across prioritized indications. 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. 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. 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. Let me now briefly review each of our pipeline product candidates. First, CHS114, our anti-CCR8 Treg depletor, and then, Casdozo Ketug, our anti-IL27 antagonist in terms of first, how they were scientifically brought forward, second, why they are so promising, and third, rationale for the development path we've chosen. Then, Dr. Dias, our chief medical officer, will review the ongoing studies and the upcoming data readouts expected in the first half of 26. First, CHS114, our potential -in-class CCR8 Treg depletor. Now, normally, T regulatory cells act as brakes on the body's immune response, preventing autoimmune disease. In cancer, particularly with solid tumors, Tregs help tumors evade the immune system, allowing them to grow unchecked. While the existence and role of Tregs was known years before, in 2016, researchers found that Treg cells in the tumor microenvironment had a unique receptor, CCR8, on their surface. This sparked a rush to create antibodies that target CCR8 with the objective to eliminate these specific Tregs and not others. And boost the immune system's response against tumors. This was viewed as a potential major breakthrough goal in the years-long battle against cancer. CHS114 was developed with great care to specifically target only CCR8, 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. And targeting such receptors is notoriously difficult, as there's so little protein on the cell surface for binding, making antibody development very challenging. The development process for CHS114 was rigorous, 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 Treg-depleting agent with no off-target binding, which may avoid unexpected toxicity. Two key points here. First, some CCR8 competitors are accounting off-target binding in their development programs, and some are finding dose-limiting toxicities. Secondly, CHS114'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 U.S. biotech developing a CCR8, and the U.S. FDA approval is highly valuable, -U.S. in terms of partnering, which is a key focus for us. We are working efficiently and aggressively, of course, to bring CHS114 to market for key indications in the U.S. as quickly as possible. And we're making good progress. With our head and neck trial, Coeris Oncology is the first U.S. company to demonstrate that anti-CCR8 treatment can deplete Tregs and tumors. 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 Lactorzy, in this same study, we saw a partial response and significant reduction of target and non-target lesions in a fourth-line patient. 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. Importantly, given the MOA, there is also the potential for broad combinability of anti-CCR8s across other efficacious modalities, such as T-cell engagers, ADCs, and so on. This is a subject of our partnering efforts, both in the U.S. and -U.S. We currently have clinical studies in head and neck, gastric, and esophageal cancer, which we will review directly. However, I wish to point out that Dr. Alexander Rudinsky, Chairman of Immunology at Memorial Sloan Kettering and key member of our Coeris Oncology Scientific Advisory Board, recently published two important preclinical papers characterizing the immune-suppressive role of Tregs in colorectal cancer, 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. We believe that in 2026, anti-CCR8s will start to realize therapeutic promise and become a new treatment backbone used broadly across many solid tumor types. Let me now refresh you on Casdozo-Ketug, a unique -in-class opportunity in our pipeline. Casdozo-Ketug is the only known anti-IL27 treatment currently in development, and IL27 plays a key role in the immune responses within barrier tissues, such as liver and lung. It is well known that cytokines and the immune system are tightly linked to cancer, and it has been demonstrated that IL27's role in mediating the immune response is the basis for its mechanism of action. Mechanistically, within the tumor microenvironment, IL27 facilitates tumor growth in three ways. First, by inducing checkpoint expression, such as PD1s, LAG3s, and others on the surface of T cells, inhibiting the immune response. Secondly, by reducing pro-inflammatory cytokines, weakening the immune response, and lastly, affecting natural killer cells, preventing them from attacking tumors. This makes IL27 a novel and distinctive target with a digital-modulatory mechanism that is synergistic with checkpoints, attacking immune resistance from a complementary direction. 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, giving us a clear path forward for development. Across preclinical mouse models, IL27 was shown to have an important role in turning off T cells and NK cells in lung and liver. 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, as previously disclosed. Coherence oncology has global rights to CasDoZoKetug, and hepatocytular carcinoma is a global disease, with particular incidence in Asia and other regions, including Europe and MENA. This makes the ex-US licensing efforts of CasDoZoKetug a priority for us, and we believe the success of such efforts will follow from strong clinical data. 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. And third, cost offsets for larger pivotal clinical trials to come later. Dr. Diaz will now provide clinical development rationale and update, letting you know what you can expect next year as the data reads out. Then, Samir Gurgaonkar, 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. Rush?