Coherus Oncology, Inc. Common Stock 2026 Global Healthcare Conference

Thanks. Thank you, Brian. Thank you.

I'm Denny Lanfear, Coherus's Chairman and Chief Executive Officer. To my left is Dr. Rosh Dias, the company's Chief Medical Officer. Let me first apprise you of the forward-looking statements and direct you to the company's regulatory filings for further details with respect to the products tagmokitug, casdozokitug, and LOQTORZI. Today, I'm first going to summarize for you the vision and the summary of the company, where the company is positioned in the cancer treatment paradigms. We'll spend a moment talking a little bit about overcoming immune resistance through T reg depletion. Of course, you're aware that we have a product, tagmokitug, which is in a number of phase I/IIs, about 6 indications by Dr. Dias and company.

We'll spend some time with you today talking about that, the progress of those clinical trials, the mechanism of action, and what we have seen so far with that. We'll also talk to you a little bit about casdozokitug, which is our first-in-class IL-27 antagonist, which is in first-line liver cancer. Coherus Oncology is focused primarily in the arena of overcoming immune resistance. The post-administration of most chemotherapy agents, a cell type called T regulatory cells develops that I'll spend a little time on talking about today. In that context, this enforces immune resistance and keeps the immune system from attacking cancerous cells. This is going to be a key MOA going forward in oncology. Today, let me just summarize 3 key things for you. We are a commercial-stage innovative oncology company.

We have a launched product, LOQTORZI, in nasopharyngeal cancer, where we are the only approved and available marketed product. I'll apprise you just in a moment about how we're moving forward with that in terms of our revenues and so on. As you see on the left side of this slide, we are advancing tagmokitug. This is a CCR8-positive T reg depletion mechanism. This product has very high selectivity. There's probably a half dozen of these products in the field right now moving forward. As I'll talk in a moment, Bristol Myers Squibb, Amgen, some others have them. However, we believe that we have the best-in-class molecule for a number of reasons, including selectivity. We have a broad development program that we'll talk about in just a moment, as indicated across 6 different indications. More importantly, we are looking forward to data readouts this half of the year.

In our last call in August, we discussed the progress with our head and neck study. Dr. Dias will give you some additional details on that today. We also have studies in gastrointestinal cancers, which include, of course, colorectal cancers. Importantly, we are also advancing this product in conjunction with Johnson & Johnson in metastatic prostate cancer. Casdozokitug is our IL-27 antagonist. This is a first-in-class product. This is a highly targeted program in first-line HCC. We have seen in the previous study very encouraging activity, including significant duration benefit with this product. We are now doing a randomized three-arm study at 2 doses we will discuss with you just in a moment, and we also have data readouts coming this half of the year.

Lastly, as I indicated, LOQTORZI, our next-gen PD-1 inhibitor, a very unique mechanism of action here, binds on a very unique epitope of the PD-1 receptor and has shown significant efficacy in nasopharyngeal cancer. Here is LOQTORZI. LOQTORZI has demonstrated significant clinical differentiation and survival. Here on the left panel, you see data demonstrating its activity in low PD-L1 esophageal cancer, for example, in contrast to Keytruda. As a matter of fact, this product is approved irrespective of PD-1 status, I should say, in Europe. In the middle panel, you see, for example, our very stellar 6-year survival data. These patients live almost twice as long with LOQTORZI plus chemotherapy versus chemotherapy alone. This profound efficacy has been rewarded with top positioning on the NCCN guidelines. It is Category 1A, both in first-line in conjunction with chemotherapy and also in second-line as monotherapy.

We have been focusing on the commercial execution of LOQTORZI in the nasopharyngeal space. This is about a $250 million opportunity all in considered. We project reaching a maximum of about $175 million annualized per year with this asset in 2026, and we expect to reach $15 million per quarter. This is important in terms of sales because at around $15 million per quarter, this product pays for the commercial opportunity, the COGS, the manufacturing, the royalties to our partner, and so on. Therefore, revenues beyond $15 million a quarter, say up to $30 million a quarter here in 2027, it starts to contribute to the company's SGA. Around $30 million to $35 million a quarter, which we project we will reach sometime in 2027, probably towards the end of the year, this will be sufficient to drive and cover the Core burn of the company, X, the clinical costs.

Our objective here then is to finance the company with the core burn on LOQTORZI. We are very tightly focused on execution around this product. Lastly, ultimately, we think this product will reach, as I indicated, maybe $175 million a year or so. That is probably the $40 million-plus per quarter, at which time there is some additional funding for various things. Primarily, that is the role of this asset in the company together with the pipeline. With respect to the revenues and so on, the key issues that we are driving on this year is overcoming Keytruda, which has been entrenched in the market prior to our launch. Keytruda has broad utilization in head and neck. Nasopharyngeal cancer is treated by head and neck physicians.

Our focus really is on educating physicians with the 6-year survival data, having claims data, which will indicate to us which particular physicians and practices have patients, and then have a broader field footprint across thought leader liaisons, et cetera, and to be able to get to these physicians and educate them accordingly when the patients come up. Here is our pipeline, and I would just point out that the role of LOQTORZI in the pipeline is both as a revenue generator in the context of nasopharyngeal, but also revenue multiplier. Whenever any of these indications with either tagmokitug or casdozokitug are approved, we will register a sale both for that novel asset and LOQTORZI. Let me talk a little bit about overcoming immune resistance through T reg depletion. T regs are immune-suppressive T cells that support immune homeostasis.

They are broadly circulating in the body, but they are particular players in the tumor microenvironment where they inhibit the immune response. That is through the mechanisms of immune suppression, cytokine release, and lastly, the degradation of the activity of all of the immune system effector cells, natural killer cells, and so on. They are prognostic for lower survival and outcomes in the tumor microenvironment. There is therefore been the hypothesis that if T regs could be depleted in the tumor microenvironment selectively, then perhaps T cells and the overall immune system would recover and you would see beneficial response. That is exactly what we are testing across a number of indications. It is important to note that cytotoxic therapies, a number of them, chemotherapy, VEGFs, KRASs, radiation, ADCs, all result in the substantial generation of T regulatory cells. This is the body's natural response to destroying cancerous cells.

This then is the secondary mechanism which kicks in, limiting immune response and thereby truncating duration. This is really important. Whenever you treat, you get a very substantial ORR with many of these therapies. However, they directly increase intramural T regs, upregulate T reg recruiting checkpoints, and induce suppressive signaling. What this results in then is a large unmet need to restore overall survival or extend overall survival. Particularly in terms of restoring potentially exhausted T cells, and enhancing the immune profile. Again, this is what we are testing with our clinical trials thus far. As it turns out, in 2016, it was discovered that T regulatory cells in the tumor microenvironment have on their surface a protein called CCR8.

It was therefore posited that if you could selectively attach to that CCR8 and you could enhance a depletion of a T reg cell with effector cells pursuant to that, then you would get rid of the T regs, particularly differentially in the tumor microenvironment, without having substantial impact on their role in the periphery enforcing normal immune homeostasis. On the left panel here, what you see is the distribution of T regs in the periphery versus the tumor microenvironment. On the right panel, you see the mechanism of action that these molecules now enhance. You have an antibody, it grabs the CCR8 on the surface of the T reg, and then this facilitates the effector cells destroying. As a matter of fact, before we get to that data, we will talk about one other thing.

We've actually developed what's called TIRI, the Tumor Immune Regulatory Index, which is associated with these cells. It's important if you pursue this that you have a way of enriching the response and understanding that you're going after cancers in which CCR8 plays a key role in the tumor microenvironment, and we have done that. TIRI is a CCR8-derived index. It is very much akin to what you see, for example, with the PD-1s, with the CPS score. You have to have a certain CPS score in order to expect efficacy. That is because it is a targeted therapy. We're actually leading in this field, but as we roll out our data from now until the end of the year with our T reg depletion MOAs, we will refer to this as a way of understanding the response.