Coherus Oncology, Inc.

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 the session, you will need to press star 1, 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 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.

Thank you, Heidi. Good afternoon, and welcome to Hill-Harris Oncology's fourth quarter and 2025 year-end earnings conference call. Joining me today to discuss our results are Denny Lansfair, Chief Executive Officer of Hill-Harris, Dr. Teresa Lavallee, Chief Scientific and Development Officer, Dr. Rosh Gaius, Chief Medical Officer, Samira Gorizoker, Chief Commercial Officer, and Brian McMichael, Chief Financial Officer. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding O'Hara's current expectations about future events. Actual 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 annual report on Form 10-A for more information on risks and uncertainties. And now I'll turn the call over to Denny.

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 Service Oncology, a transaction through which we acquired two very promising assets, Tagnoketuk, a potentially best-in-class CCRA Treg cell depleter, and Casdozo-Ketuk, 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 in convertible debt by over 90% to $38.8 million, reduced our headcount and expenses, sharply refocusing the company. 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, cross our pipeline products in combination with Lactorsi as well as partners' products, potentially enabling the initiation of a registration trial in 2027. You will hear details of our clinical strategy and progress from Dr. Raj Dias, our Chief Medical Officer. We also launched our first innovative oncology commercial product, Lactorsi, in 2024. a next-gen PD-1 inhibitor as the only available and approved product for recurrent, locally advanced, or metastatic nasopharyngeal carcinoma in the U.S., a $250 million addressable market. We have made very rapid progress on our transformation in the context of our products, our development strategies, and our dealmaking. Let me provide you then with a strategic lens through which to view the company going forward. First, to our financial strategy. Lactorsi plays a foundational role as both a revenue generator in the context of MPC and revenue multiplier in the context of combination therapy with our pipeline assets. I believe Coheris is unique as a clinical stage small biotech company because we have a commercial asset with growing sales in a rare disease space with no FDA approved competing products on the horizon, outstanding six year survival data, and we are positioned at the top of the NCCN guidelines for recurrent metastatic MPC. This gives us confidence in Lactori's continued growth. And as you will hear from my colleagues, Lactorsi more than doubled its sales in 2025 over 2024. We view Lactorsi as reliable, growing, non-dilutive revenue source and financing vehicle to support operations while we advance the promising pipeline, increasing in value along the way. That's its fundamental role. Our expected trajectory achieves peak market share sometime in 2028, corresponding to $175 million in annualized revenues, or about 70% market share of the $250 million market total. You will hear more about that from Samira Gorogakar, our Chief Commercial Officer, in just a moment. But let me make some key observations for you. First, while $175 million a year revenue may appear modest, It's very important to us, as it's more than sufficient to fund our quarter burn and overall headcount, not including development costs or other strenuous items like stock option expense. 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 $30 to $35 million per quarter, our quarter 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 Tegno Keto clinical program, as the Treg field is increasingly competitive with some expected data readouts by other parties this year. Given the recent raise in our financial plans, we believe we are certainly sufficiently funded through Keto Day Rayouts in 26 and on into 2027. My Chief Financial Officer, Brian McMichael, will provide more color in just a moment. Now let me turn to our product strategy. In addition to Lactorsi, we have two well-positioned product candidates, both showing promising early clinical results. Their differentiated key attributes provide risk diversification for investors. On the one hand, we see Pagmo Ketog as potentially a best-in-class in a competitive space with broad clinical therapeutic utility and very promising biology. In a moment, Dr. Lavalle will provide you some additional scientific insights on its mechanism of action and combination therapy considerations. The breadth of potential utility mandates broader early stage clinical investigation, so we have several trials underway. 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. On the other hand, we also believe that Caslodoketog is the first and only in class, and with impressive translational data sharply focused on barrier tissue cancers, such as liver and lung. Consistent with that data, Caslodoketog demonstrated highly durable, complete response rates in first-line hepatocellular carcinoma. A follow-on trial is underway, and Dr. Dias will describe this to you subsequently. Lastly, let me talk about the deals. Coherence 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. 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 T-reg depletor 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. And lastly, it shows that we have constructed a strategy that is both executable and potentially accretive to shareholders. As you know, we have global rights to TACNO-KTUG and CASDO-SO-KTUG, and we look forward to XUS 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 registration trial costs as they carry the expenses for the patients in their territories. This will leave us responsible for a minority share of overall cost, which we expect to be manageable. In closing, let me summarize for you. Over the last 18 months or so, we've 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. Teresa Valle, 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. Teresa?