Coherus Oncology, Inc.

Results may vary significantly, and we undertake no duty to update or revise any forward-looking statements. Please see the press release that we issued today and our quarterly report on Form 10-Q for more information on risks and uncertainties. And now I'd like to turn the call over to Denny.

Thank you, Carrie, and good afternoon, everyone, and welcome to our Q3 2025 earnings call. As we get started, let me first welcome Arvind Su to Coherence Oncology, our newly appointed Chief Strategy and Corporate Affairs Officer. Arvind is responsible for investor relations, corporate development, and government affairs. Welcome, Arvind. Thank you. Things are going very well, and today I'm very excited to tell you about the progress we have made on our strategic plan in the last quarter, as well as generally recap our progress for you over the past year as we approach the end of 2025. As you know, we take great pride in our ability to execute, and execution has been strong across the board. For example, you may recall last year me telling you that our objectives included driving the top line, reducing expenses, and strengthening the balance sheet. I'm happy to report we've made great progress across all three. We are particularly pleased by the progress on the balance sheet and expenses, which shows substantial improvement over the past year. My Chief Financial Officer, Brian McMichael, We'll discuss these results with you directly. Now, the Coherence Oncology value proposition for investors is all about our drugs, our evolving data, and the opportunity for deals. We have set ourselves up for success with a sound strategy and have gained significant momentum and hit our stride. Regarding our drugs, Lactorsi is the next generation PD-1. Active in low PD-L1 cancers and approved in nasopharyngeal cancer, where it is a revenue generator for us. providing growing sales and margin contribution. Our chief commercial officer, Samir Gorogargar, will give you the color and detail on that shortly and reiterate our confidence that we will achieve our revenue targets. Our focus as a cancer company is achieving a step change in patient survival. That is our goal. We believe the future of extending patient survival lies in combinations. And we are combining Lactorsi with both our own proprietary pipeline assets across indications. Lactorsi is also being used in combination with other companies' therapeutic assets, and upon approval of any of these drugs, will be a revenue multiplier, its second key role in our strategy. We are currently pursuing liver and lung cancer with Casdose Oketuk, and with CHS114, our CCR8 Treg depleter, we are pursuing head and neck cancer, gastric cancer, esophageal, and now colorectal cancer, an area of expanded focus for us, all in combination with Lactorsi. Which brings me to the second thing for investors to keep in mind, our data. In just a moment, Dr. Raj Dias, our Chief Medical Officer, will update you on our enrollment and clinical trial progress in more detail. But I will note here that enrollment across all of the initiated studies is in full swing and on a global basis. with a vast majority of our sites open as we try to deliver data for you next year in these promising indications. With clinical development, we have hit our stride, and with highly engaged clinical investigators enthusiastic about these highly promising mechanisms of action in enrolling their patients suffering from their unmet need to stop their cancers. Dr. Teresa LaValley, our Chief Scientific and Development Officer, will spend a few minutes with you today discussing the mechanism of action of our drugs, with particular focus on the therapeutic promise of T regulatory cells as a target. As you know, this field was the subject of a recent Nobel Prize in Physiology or Medicine, thrusting it to the fore and underscoring its therapeutic potential. As a leader in this rapidly advancing field, Coherence Oncology is proud to be the first company to demonstrate Treg depletion and subsequent CD8-positive T cell infiltration in a patient. The organizers of the 2025 CITSE meeting invited us to present our data at a webinar recently, which was the highest attended of the year. CHS114, our highly selective CCRA Treg depleter, is potentially best in class. And given the broad distribution and role of Tregs in the body, selectivity takes out a dominant role. With our broad yet focused clinical program reading out over 2026, we are well positioned to continue the scientific leadership that we demonstrated in 2025. We have global rights to CHS 114, as well as Cas Dozo Ketog. So let me make a few comments about potential deals. The third part of our value proposition investors should keep in mind. Treg depletion is potentially complementary mechanistically with a wide variety of existing therapeutics where the proportion and density of T regulatory cells is correlated to poor outcomes. Recall my earlier comments about combinations. This means that adding something like CHS114 to ADCs, bispecifics, or radiation treatment, or other therapeutic approaches may improve outcomes and extend survival. We are pursuing such partnering opportunities, both in the U.S., where we are commercially focused, but also globally ex-U.S., where we are not focused yet have full rights. Such arrangements will provide us with income from upfronts to offset ongoing clinical development costs, but more importantly, cost contribution to pivotal or registrational trials, which need to be conducted globally. Over the next 6, 12, and 18 months, we can expect our emerging clinical data to drive such deals, and we'll keep you updated on our calls. And with that, let me hand it over to Teresa. Dr. LaValle?

Thank you, Denny, and good afternoon. I'm excited to update you on Coherence Oncology's innovative pipeline team to advance cancer treatment. Let me start with this year's Nobel Prize for Physiology or Medicine, recognizing the importance of T-regulatory cells and immune homeostasis. If T-rays are defective or missing, this results in severe autoimmune disease, providing strong evidence for the critical role these cells play in peripheral immune tolerance. Tumors exploit these cells as a key mechanism to evade the immune system. This is a problem because it results in cancer growth and progression. The presence of T regs in tumors is known to be associated with poor outcomes to any cancer therapy, including chemotherapy, radiation, and of course, PD-1 inhibitors. While this is well known, what has been a problem in the field is a way to selectively target T regs in the tumor and not in peripheral tissue. CCR8 is a protein preferentially expressed on tumor resident Tregs, enabling a targeted therapy approach to selectively remove these immune suppressants in the tumor. We have been focused on CCR8 as a drug target for several years and believe our program is set apart from the field. CHS114 is a cytolytic antibody with ADCC enhancement. designed to find and kill CCRA-positive Tregs. This mechanism is akin to an ADC molecule, and in this case, the payload is enhanced effector function leading to Treg killing. Our preclinical and clinical data have shown differentiation, potency, and tumor response. CHS114 was evaluated for binding to over 5,000 human proteins, the entire proteome available on the outside of the cell. Importantly, CHS114 only binds to one protein, its target, CCR8. Eliminating off-target binding has the potential to have a differentiated safety profile. CHS114 is the only known selective CCR8 antibody. Additionally, it has shown an acceptable safety profile, selective CCR8 T rate depletion in tumors, and also a remarkable ability to lead to the increase of CD8 T cells in tumors, thus characterizing the tumors as hot or immunologically responsive. In the initial safety cohort of seven U.S. patients evaluating CHS114 with toropalimab, response was observed in a fourth-line head and neck cancer patient. All of these data not only show the idea works, targeting CCRE will mainly remove tumor Tregs, but also show CHS114 treatment remodels the tumor to be more immune active. This weekend at the annual CIPI conference, we will present additional biomarker data showing significantly enhanced immune activation in head and neck cancer patients following CHS114 treatment with toropalimab. This is important as we are testing whether the combinations of CHS114 with toropalimab can overcome PD-1 resistance in refractory patients. CHS 114's pharmacological and clinical attributes establish it as having good drug-like properties. And this coupled with our program's focus on generating data to address two areas of increased scrutiny by the U.S. FDA. First, data in a Western population. And second, dose optimization. Establish our scientific leadership in the space. The last point I want to make on CHS114 is that it is a targeted therapy. So, we know who to treat, essentially tumors with a high prevalence of CCR8, its target. Tumor types that have a high degree of CCR8 include lung, colon, head and neck, and gastric, to name a few. Coherent oncology is prioritizing some of these tumor types. and is now enrolling in a new cohort evaluating CHS114 and toropalimab in a patient population without any approved immunotherapy yet, microsatellite stable colorectal cancer. The clinical program is designed to generate data on a variety of solid tumors and further inform where CHS114 and toropalimab treatment results in meaningful clinical benefit alone or in combination with chemotherapy. Now switching gears to discuss our other promising clinical program, Cas-Dosa-Ketad. Another approach to overcoming immune evasion is activating NK cells. T cells and NK cells are the body's immune killer cells. Cas-Dosa-Ketad coheres oncology's first-in-class IL-27 antagonist, results in immune activation of both T and NK cells. At this week's International Cytokine and Interferon Society meeting, we presented preclinical and clinical biomarker data showing an important role for NK cell activation and cast dose of T-tugs efficacy, particularly in first-line HCC, a tumor type rich with NK cells. The updated biomarker data continue to support that Casdoza key tug treatment leads to inhibition of IL-27 signaling and enhanced cytolytic immune activity by NK and T cells. Why is this important? Two reasons. One, Casdoza key tug treatment results in strong NK cell activation. may give a mechanistic explanation for why the results showed a more than doubling of the complete response rate. Activating both NK and T cells could optimize tumor cell killing and lead to its disappearance. The second reason I highlight this is that when a new drug is added to standard of care, we need to show the contribution of components. Or said plainly, if Cas-Doza-Ketect adding anything to standard of care. These data give further confidence the deepening of response is associated with Cas-Dosa-Ketad treatment, since patients who respond show IL-27 inhibition and significant NK cell activation. Also, I want to reiterate Denny's comments that identifying partnerships that accelerate the development of the pipeline is a priority. We own global rights for both, and and these compelling clinical data across the 2 pipeline assets are supporting discussions with potential partners. Before I turn it over to rush, let me just summarize why we are excited about recent developments with our key pipeline molecules. We were thrilled the Nobel Prize for Physiology or Medicine recognizes the importance of T regulatory cells in immune homeostasis. We'll present biomarker data at SISI meeting this week showing enhanced immune activation in head and neck cancer patients following treatment with CHS114 in combination with toropalimab. Also, our presentation of biomarker data earlier this week at the International Cytokine Meeting provides further support of Casdoza-Ketog's contribution on top of standard of care in liver cancer patients. With that, I'll turn it over to Dr. Diaz, who will further describe the clinical development.