Coherus Oncology, Inc.

Good day, and thank you for standing by. Welcome to the Coherence Biosciences first quarter 2025 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 the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jody Seavers, Head of Investor Relations. Please go ahead.

Jody Seavers Thank you, Shannon. Good afternoon and welcome to Coheris Bioscience's first quarter 2025 earnings conference call. Joining me today to discuss our results are Denny Lamphere, Chief Executive Officer of Coheris, Brian McMichael, Chief Financial Officer, Dr. Raj Dias, Chief Medical Officer, Dr. Theresa LaValley, Chief Scientific and Development Officer, and Samir Gurkalkar, Executive Vice President, Commercial. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coheres' current expectations about future events. These statements include, but are not limited to, the following. Expectations about repurchasing Coheres' remaining convertible notes, projections of cost savings from headcount reduction, timing for Coheris to release data from its clinical trials, and projections of future expenses. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties that are discussed in our press release that we issue today as well as our quarterly report on Form 10Q. Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements. And now I'll hand the call over to Denny.

Thank you, Jody, and thank you, everyone, for joining us today on our Q1 2025 earnings call. First, let me say that with our biosimilar divestitures behind us and our promising innovative oncology business in front of us, We are fully focused on innovative oncology. We are now a commercial-stage innovative oncology company with an FDA-approved next-generation PD-1 inhibitor, Lactorsy, as well as two highly promising proprietary pipeline products moving quickly through early to mid-stage clinical trials and demonstrating positive data for large markets. Our strategy is anchored around three core pillars. that drive both our near-term revenue growth as well as our long-term innovation as we strive to extend the survival of cancer patients. The first pillar is toropalimab, our next-generation PD-1 inhibitor, brand-name lactorsine, which is the only FDA-approved and available treatment for metastatic recurrent locally advanced nasopharyngeal carcinoma in all lines of therapy and the standard of care in MPC. Demonstrated to be efficacious in a number of cancers, and active in low PD-L1 tumor types, toropalimab derives its differentiation from its unique binding epitope on PD-1, the FG loop of the receptor. We have demonstrated that this results in differential and superior signaling within the T cell. Clinically, in at least three Phase III studies, toropalimab in combination with chemotherapy has shown efficacy irrespective of PD-L1 status. These properties make ToroPAL ideal as a combination agent for other cancer therapeutics, which I will discuss directly. The Lactursi growth is now focused on increasing the breadth and depth of market penetration, driven by strong NCCN guidelines, as well as the duration of treatment in patients to maximize patient benefit. Unencumbered by the strategic diversions in the last two quarters, that is the divestiture and the supply interruption issues, as well as the field team remapping efforts, it's now clear that our commercial team will be able to deliver consistent growth going forward. Samir Gorogalkar, our Executive Vice President Commercial, will be describing this for you in greater detail in just a moment. We project Lactorsi in just the NPC indication alone will grow to about 150 to 200 million annually over the next three years, providing non-dilutive funding for the development pipeline as well as being an important source of revenue going forward as we seek to expand its indications and non-NPC sales. Once we exceed about $15 million per quarter, we will cover our commercial costs and begin to contribute to corporate expenses, progressively moving to cover R&D costs with revenues. A key development focus is on expanding the indications for Lactorsi in combination with other agents, including our own, to extend patient survival across tumor types which creates a market opportunity for current pipeline candidates of over 15 million annually. A key part of this is an elegant, efficient, and aggressive indication expansion strategy based on partnerships, whereby we supply drugs to various partners who then fund all other clinical trial costs themselves. Once approved, these partner combination agent labels will specify TORPALMET. We have put several of these agreements in place, which include pivotal trials, such as with Inovio and HPV positive head and neck cancer, as well as a number of earlier stage assets. Our objective is to be the preferred partner of choice for companies needing a safe and highly efficacious next generation PD-1 inhibitor. More such arrangements are in the process. Additionally, our partner Junshi, has a pivotal study underway with toropalimab in combination with BTLA in small cell lung cancer subtype, which would also provide an additional approved indication. We are also developing additional indications for toropalimab in combination with our proprietary pipeline, which includes Casdozo ketone, a first-in-class anti-IL-27 antibody, and CHS114, our CCR8 cytolytic antibody in several cancers. We believe that the broad therapeutic promise of selective Treg depletion in a tumor microenvironment facilitating the infiltration of CD8 positive T cells to attack the tumor may finally be realized with a sufficiently selective CCRA acetylic antibody such as CHS114. Ourselves and others believe the anti-CCRA class could see broad flexibility across a number of solid tumors, turning cold tumors hot in constituting an emerging cancer therapeutic superclass synergistic with other modalities such as T-cell engagers, ADCs, bispecifics, and others. Accordingly, our development efforts with CHS114 constitute the second pillar of our value creation strategy. We believe that CHS114 is potentially best in class as it is highly selective in the product of an extensive product candidate selection process. that resulted in the only CCR8 agent with no off-target binding. What is most striking about this program and what gives us such confidence is the translational read-through from binding to Treg depletion to CD8 positive T cell tumor infiltration to clinical efficacy. We recently presented the first U.S. clinical data with a CCR8 at AACR last week. showing visually compelling biomarker data illustrating the elimination of T-regs, infiltration, and inflammation of the TME by CD8-positive T-cells. Remarkably, in this study, there was also a partial response showing tumor shrinkage in a very advanced fourth-line head and neck cancer patient, which Dr. Dias will discuss directly. We believe that our very thorough and deliberate scientific translational approach in developing data sets Physician coheres as the thought leader expert in this rapidly evolving field of such high promise. The third pillar of our development value creation strategy focuses on pioneering novel treatment paradigms in the first-line hepatocellular carcinoma, a significant unmet need with large market potential. These efforts are centered on Casbosoketog, our first-in-class anti-IL-27. Earlier this year, we announced very compelling data in first-line liver cancer. where five out of 28 patients, some 17%, had complete response in a Phase II efficacy study of Cas-CoV-2 combined with Atenzo and Bevacizumab. This compares very favorably to the standard of care alone or even other studies in this indication. Building on this very positive data, we are now conducting Phase II trial evaluating Cas-CoV-2 with lactorazine and Bevacizumab. We expect data in the first half of next year. Also in liver cancer, our partner Jun Shi is conducting a phase three pivotal study with LactoRZ combined with Linvatinib. We should read out the next three to six months. If successful, we will seek to engage the FDA regarding potential approval approaches. In summary, for the development and value creation strategy now, let me make two key points for you. First, as you know, we felt it essential as an innovative oncology company to have an approved and proprietary PD-1 inhibitor. It is now apparent why. Such an approach first allows great latitude and cost savings while developing your own synergistic combination agents. This offers the opportunity for others to embrace your PD-1, co-develop it with their own assets at minimal cost to coherence as we realize expanded legal indications and result in higher revenues. Additionally, When your PD-1 is combined and approved with your own proprietary agents, you set up the opportunity to realize sales multiples by realizing revenues on both agents, because as your novel agents get approved, you can mark your PD-1 right alongside. My second key point is that clinical data readouts that are occurring in 2025 support these product candidates with safety, initial efficacy, and proof of mechanism data. that builds momentum as we look forward to initial key data readouts for these studies projected in the first half of 2026. Today, you will hear next from Dr. Teresa Lavalle, our Chief Scientific and Development Officer, who will be followed by Dr. Raj Dias, our Chief Medical Officer. Dr. Dias will provide you with an update on clinical trial rationale, study designs, and progress to date. Then you will hear from Sameer Gurgaonkar, our Executive Vice President Commercial. Sumir joined us late last year to lead the Locktory franchise and will give you a detailed rundown on the key market drivers impacting revenues, uptake, and the like. Following that, I will turn the call over to Brian McMichael, our Chief Financial Officer. Brian will review the closeout of Q1, the divestiture of the Eugenica business, and financial impact of these discontinued operations. He will also review the Q1 overall numbers and provide STNA guidance looking forward through the end of 2025. Now with that, I'll turn the call over to Dr. LaValley to review the scientific rationale of our pipeline product candidates and the expansion strategy for Lactorsi. Teresa will particularly focus on the biology of the emergent CCRE class, including CHS114, which is a preeminent candidate given its high selectivity. Teresa.