Afternoon, everyone. Thanks for being with us at the Baird Global Health Care Conference. My name is Colleen Coosey. I'm one of the Senior Analysts covering biotech. Today, I am pleased to have with us Coherus Oncology, including Denny Lanfear, CEO, and Theresa Lavallee, Chief Development and Scientific Officer. Denny, Theresa, thanks for being with us today. Thank you so much for having us, Colleen. To kick things off, why don't you start with a company overview of Coherus BioSciences? Obviously, there's been some changes over the years. What are the current state of affairs at Coherus BioSciences? Thank you. Thank you for the question. Coherus is an oncology company that is focused on providing a step change in survival for patients with cancer. Our value creation lens that we view is really comprised of three key things. The first is our drugs. The second is the data that we'll generate. The third is our deals. With respect to our drugs, we have the next-generation PD-1, as you know, LOQTORZI, which has a very unique binding to the PD-1 site and has very high affinity. It's demonstrated its next-generation capabilities in low PD-L1 states, such as in esophageal cancer, and really some extraordinary data in nasopharyngeal cancer where we launched it last year. The other product that we're very excited about is CHS-114, which is our CCR8 molecule that Dr. Lavallee will talk about subsequently. This is a very, very exciting space. We think this is an emerging space for oncology next year. T-regulatory cells play a key role in stopping T cells, CD8-positive T cells, from attacking tumors in the tumor microenvironment. CCR8 agents, which deplete T-regulatory cells, are very, very important. We were the first team to show, first of all, the depletion of T-regulatory cells in the tumor microenvironment led subsequently to the infiltration of CD8-positive cells. In that very same study, we saw partial response and significant tumor mass depletion in a fourth-line patient. The other product in our pipeline that we're really, really excited about is KEZDOSE, which you know. That's our IL-27. IL-27 plays a key role with pathogens when they infiltrate barrier tissue, such as liver and lung. It enforces homeostasis, so the immune system does not get out of control and actually turns off after the pathogens are dealt with. We have seen very good activity with IL-27, as you know, in hepatocellular carcinoma, first line, where we saw a 17% complete response rate, which is more than twice the underlying therapy. Also, we are investigating this in lung tissue. We're very excited about the data that will be coming out next year with IL-27. I think the third aspect of the company, which is really important, is the deals. Deals and how we collaborate in the environment sets us apart. As you know, our strategy really is to stay within the U.S. We have global rights to both of our products, both to KEZDOSE and CHS-114. Over the course of the next 6, 12, and 18 months, you'll see us go ahead and prosecute these deals with respect to these external territories with other partners. I think that when we get these licensing transactions done, they'll do three things for us. The first thing that they will do, of course, is validate the platform, the value of the products, and the clinical approach. The second thing is the upfronts and the funds we raise will help us offset some of our own development costs here in the U.S., where we're commercially focused. The third thing they will do is help us defray the longer-term costs associated with the phase three and the pivotal programs, which can be important. We're currently looking for partners in a number of territories and setting the table for that. We expect, as the data evolves with the pipeline over the future, that we'll be able to get those off. We think that'll be important value drivers for the company. Great. Super helpful overview. Before we get into the programs, I did want to just talk for a minute on the company's transition to a full-fledged oncology company. I think when people hear the name Coherus, they might still think of the biosimilar company of before. As part of this transition from a biosimilar company to an IO company, you've executed a number of BD deals. You just talked about some future deals, but you've had some very successful BD deals that you've executed in the past. Maybe just walk us through some of those strategic deals you've completed over the last year or so and the current financial state of the company. I think the deals went well overall. Thank you. I think it's a I admit we did better than we'd hoped. We managed to, I think, divest a couple of our biosimilar assets, all of them, actually. Our ophthalmology asset was divested for almost $200 million. Of course, the eudynica asset was divested for about $558 million, and also the IMIRA assets. That allowed us to pay down some $480 million in debt. It's about $800 million of the deals. Wow. We are on a market capitalization of about $150 million. Yeah, impressive work. Thank you very much. We were able to push $250 million to the balance sheet and support Dr. Lavallee's spending on the clinical trial program. We're pretty happy about that. I think that we do have a very strong deal team at the company. I think it particularly will come into play as we look forward. One of the things that we've done is put a strategy together in which we take our products, such as LOQTORZI, and we put them in the hands of others. We just provide the drug. What that allows them to do is to go ahead and develop their products concurrently all across us. It's just the material cost for manufacturing. When those products are ultimately approved and we see the label, we can promote on that. That sort of getting your drugs developed for additional indications on others' time, I think, is a very unique strategy. In the U.S., we intend to do that with our other products, though, too, with the CCR8 and with KEZDOSE, CHS-114. We'll happily put that in the hands of third parties with respect to their various indications and co-development. I think that providing step change in patient survival really requires combinations. Combinations require collaborations and working with other people. I think we're known as folks that are very easy to work with, with very strong science. Great. Let's dive into LOQTORZI, your approved anti-PD-1 inhibitor, approved almost two years ago in nasopharyngeal carcinoma. How large is that market? How has that launch performed versus your expectations? LOQTORZI is about a 2,000-patient-per-year incidence market. We estimate it's about $150 to $200 million. We've been in that market, as you indicate, for about six quarters. It's a rare disease. One of the issues with that market is that the community oncologists may not see a patient every one or every two years. They're very busy, and there's a lot of folks talking to them about various things. We have embraced a number of educational programs with the community oncologists to give them a clear understanding of the benefits that are there with LOQTORZI. That's really not a tough sell, given the fact that the progression-free survival went from about 8 months to about 21 months on a background of chemotherapy. It's very easy, in an educational sense, to bring those community oncologists up to speed. You have to track them down and find the data and so forth and find out when they have patients. On the other side, I think we've done very, very well with the NCCN. We have 90% of the NCCN institutions that have ordered or have put a patient on LOQTORZI. They're very well aware of it. We've done very well on the NCCN guidelines, where we are the only preferred category 1 therapeutic above all. That makes life very, very easy, and it makes that explanation really clear. I think what you'll see, though, with respect to LOQTORZI going forward is this ramp up to $150 to $200 million over the next, I'd say, three years, as we approach probably mid-2028. That's our goal, and I think we're on that trajectory. Great. Can you just speak to the uptake of LOQTORZI that you're seeing in the community versus the academic setting? We find that the academics probably focus a little more on the guidelines and the NCCN guidelines, and so they're easier to get to. That means that with the community setting, you have to take a little different approach educationally. We have, I think, very complete programs in terms of media and digital that we're prosecuting there. It's a little slower, but as I indicated, once they understand the value and the data, it's a very short conversation and easy sell. Great. Now we'll move to the clinical side, focusing first on CHS-114, your anti-CCR8 antibody. Could you just talk about CHS-114's approach with targeting CCR8 and what kinds of solid tumors express CCR8 positive? I'll let Dr. Lavallee take that one. Yeah. As Denny Lanfear started in his opening remarks, obviously, the immune system is made with turning it on and turning it off to maintain homeostasis. T-regulatory cells are a key cell type to turn off the immune system. We've seen a variety of approaches in cancer to target them because it's well understood that tumors that have a high degree of T-regulatory cells are poorly prognostic. For immunotherapy, it causes PD-1 resistance. Even for radiation and chemotherapy, it attenuates anti-cancer responses. The problem with the approaches that have been taken in the past, targeting CCR4, CTLA4, IL-25 receptor, is that it broadly depletes T-regs, so then you have autoimmunity. CCR8 was really a seminal finding in that when it was found, it was found to be preferentially upregulated in tumors, so it's a targeted therapy. We preferentially target the T-regulatory cells, the most immunosuppressive T-regs, the CCR8-positive T-regs in tumors. We've characterized where the target is prevalent, and it's prevalent in a large number of solid tumors in particular. Head and neck, cervical, and gastric have over 85% of their T-reg cells expressing CCR8 positive and a very high density. Tumor types like lung, breast, colon, esophageal, a whole bunch of them have more than 50% of the T-reg CCR8 positive with a high density. We're seeing people report data and our own data showing activity in those tumor types. We think it's a very broad opportunity for combination with PD-1 to overcome PD-1 resistance, also with a variety of other modalities. As Denny Lanfear mentioned in his opening remarks, the thing that surprised me, which is always fun to get surprised with data that's better than you expected, is we not only, when we treat patients with CHS-114 monotherapy, we significantly deplete the T-regs in the tumor, but there's this marked infiltration of CD8 T cells, which is really what you need for immunotherapy when you think of T-cell engagers, PD-1 inhibitors. If there aren't T cells in the tumor, you can't reinvigorate the immune system. We think that there's broad potential with LOQTORZI combinations, also other modalities. Great. You recently presented data for CHS-114 with and without LOQTORZI in head and neck squamous cell carcinoma at AACR. Kind of walk us through what some of the early clinical data for your asset has shown so far. Sure. Our phase one was a first-in-human study. The dose escalation we presented at ASCO a year ago. At AACR this year, we took two biologically active doses into expansion phase as monotherapy and in combination with LOQTORZI as a safety cohort in head and neck cancer because it has a high prevalence, a high density. It also includes nasopharyngeal carcinoma, where LOQTORZI is marketed as a subset of head and neck cancer. It complements the known activity for LOQTORZI in that disease type. What we showed was safety, which is also one thing I forgot to mention. The key is that CCR8, CHS-114, has shown a really nice safety profile. No autoimmunity, no infusion-related reactions, which is commonly associated with these ADCC enhanced antibodies. That was also a nice surprise. No DLTs in combination with LOQTORZI. In that safety cohort, we saw a partial response in a fourth-line head and neck cancer patient. That was part one, which was dose escalation. Part two was the initial expansion in head and neck, both as monotherapy and then the safety cohort with LOQTORZI. Part three is now the full expansion at the two pharmacologically active doses of CHS-114 plus LOQTORZI. That's actively enrolling. We plan to report on that early next year. Great. Maybe touch on some of the biomarker data that you've generated so far and how you think about the ability of CHS-114 to remodel the tumor microenvironment. Yeah. When I say we had two pharmacologically active doses of CHS-114, that was said looking at the preclinical work to really have target trough PK levels. We achieved those. It was very remarkable, and we showed this in the AACR poster, that if you look at markers of immune activation, like interferon gamma and other immune cytokines, there was a big difference at dose level 5 and above compared to dose level 4 and below in showing immune activation. That really translated well when we looked at the tumor biopsies at dose level 5 and 6, where we show greater than 50% T-reg depletion up to 97% in the tumors. Both those doses are biologically active. With the depletion of the T-regs, we've shown marked infiltration of the CD8s. That would correspond with the response that we saw very early on in the head and neck. Super excited about this program. Great. You spoke to the data in head and neck cancer, but you're also developing in a number of different tumor types. Please walk us through the development program for CHS-114. Yeah. It's a targeted therapy. As I said, we know where the target is, which is a broad opportunity. We, as a small company, are trying to be highly focused on getting to proof of concept in ways that we can really bring it forward. Looking at the highest density from head and neck cancer, also gastric cancer, that cohort is enrolling. We'll report out on that next year, and then other GI tumors. Denny mentioned that toripalimab has differentiated activity in first-line esophageal squamous cell carcinoma, where it's one of the only PD-1s that's shown activity in combination with chemotherapy and PD-L1 low. In fact, Europe has approved toripalimab in esophageal squamous cell carcinoma, irrespective of PD-L1 status, which is different than pembrolizumab, Tizi. We're looking at GI tumors, such as esophageal and colorectal cancer as well. Great. Exciting. You're really the only CCR8 antibody that hasn't been acquired yet or is sitting at a large pharma company. How does the profile of CHS-114 compare to the other assets out there? Should we be looking for any updates from the field broadly for CCR8 in the coming year? Yeah. The CCR8 is a G-protein coupled receptor, which is one of the most common targets for drugs. Over half the drugs approved in the U.S. target GPCRs. There are only a couple of antibodies approved, and that's because of the way that the protein is structured. It's very difficult to generate antibodies that are highly selective to a GPCR. We've profiled a number of the competitor antibodies. Importantly, in our own target identification lead ID for discovery, it was the only antibody that exclusively bound CCR8. CHS-114 was one and only one that we've seen that only binds that. Why that's important is because off-target binding can lead to toxicity, as well as PK problems. You discover that pretty early. We feel that we can really characterize the safety profile. We have good potency. We've shown that hits the target, tickles the target, depletes the T-regs in the tumors, and that safety profile is really bearing out. It's the only selective one. In combination with LOQTORZI, I also think is a differentiation. To your other point, through the lens of the companies and the geographies, we are the only small independent company with a CCR8. We like to think, of course, that we have a best-in-class CCR8 for the reasons that Dr. Lavallee outlined. There are a few big pharmas, Gilead, Amgen, and others who are prosecuting these, as well as some Chinese teams. I think that we have a very agile and well-focused team and a very good product. I think you'll see some good data come out mid-next year, if not from us. It's globally unpartnered. As I indicated in my opening remarks, that's one of the key things we wish to do is have people join with us as we move it forward. Great. Moving to KEZDOSE, your anti-IL-27 asset, where you guys are first-in-class. I assume that's maybe a mechanism that is a little less understood by the street. Maybe just talk a little bit more about the rationale for targeting IL-27 for cancer. Sure. It's pretty well understood. Obviously, there's a lot of successful marketed antibodies against cytokines that inhibiting a cytokine can rebalance the immune system. KEZDOSE, a key tag, is the first antibody in oncology to show that inhibiting a cytokine can rebalance the immune system. Not only did we see dose-dependent immune activation in the first-in-human dose escalation study, but importantly, we saw monotherapy responses in tumor types that the preclinical models told us. It's an immune regulatory cytokine. We always like to think of things, are they immune suppressive? Are they immune activated? I remind people, it's an immune system. It really is a bunch of checks and balances. It depends upon who your neighbors are, how you behave. IL-27 is immune suppressive in these barrier tissues when they're challenged with an immune response. Lung and liver is where the mouse told us the tumor had to be present. Infectious disease models, lung and liver is where IL-27 inhibition really impacted the immune activation. Those are the tumor types that we're pursuing. As Denny mentioned, it has a very nice safety profile, which is important, particularly as you go into first-line oncology indications because toxicity can compromise overall survival. The safety profile in combination with PD-1 axis inhibition and VEGF inhibition is similar to the doublet standard of care profile. That depth of response, that 17% CR rate, which is really more than double what's been reported by any other program in HCC, has shown that that's differentiated in the contribution of effect of KEZDOSE, a key tag. We're actively enrolling that study and super excited to see the data next year. Very exciting. Yeah, now you're evaluating because you previously presented data in combination with atezolizumab and bevacizumab in frontline HCC. Now you're enrolling studies with your own PD-1 inhibitor, LOQTORZI, and bevacizumab in frontline. Maybe just walk us through that trial design and how enrollment is going there. Yeah. It's a randomized study against the Tori Bev versus KEZDOSE, Tori Bev. We're doing two doses to address Project Optimus. Even though all of our immune activation, all of our responses were seen at the biologically active dose, the FDA is mandating that we do two doses to address Project Optimus. There's a 1,400 milligram and a 700 milligram dose. Since we don't have safety issues, it's fine. It's a 72-patient study. We'll have 48 patients with KEZDOSE plus Tori Bev against the comparator arm. When can we expect data from the triple combination? This isn't going to make anyone happy to hear that we will see the initial report early. We plan on reporting top-line results in the first half of next year. What we saw from the atezobev triplet is that when we first looked at the data, we had a 27% response rate and no CRs. Six months later, it was a 38% response rate, three CRs. A few months later, we had the five CRs. That duration and depth of response took time to mature. We'll have an initial look-see where we want to see at least comparable activity across the arms, and then we'll wait a little while to see if that matures and deepens. OK, great. What would be the next steps from here? You'd run a phase 3 randomized study. You're also evaluating KEZDOSE in second-line squamous non-small cell lung cancer. What's the latest on that development program? Yeah. We had two monotherapy responses in squamous non-small cell lung. Both of them were PD-1 experienced, PD-L1 low, in highly refractory patients. We're working with a cooperative group to run that study. They're very excited about evaluating KEZDOSE, a key tag alone in squamous cell carcinoma, as well as in combination with toripalimab. We're working actively with them, and we'll update as they get ready to activate the study. Great. Beyond hepatocellular carcinoma and non-small cell lung cancer, are there any other tumor types that you think would make sense for future KEZDOSE development? There are a lot of places where it's highly expressed. Going with the mechanism where we've seen this activity, there's a variety of other tumor types. There was tumor shrinkage in a pancreatic cancer patient in phase one as monotherapy. Triple-negative breast cancer would be another tumor type that could make a lot of sense. Even gastric and head and neck have high expression of IL-27. Our idea is to really focus where we've seen activity, get that proof of concept, and then go broader. Great. For now, as far as we know, you're the only in class as well, right? Yes. You're first in class, only in class for IL-27. That's great. Maybe talk a little bit more, if you can, on the potential BD opportunities for CHS-114 and KEZDOSE. As I indicated in my opening remarks, we have global rights to all of these. The first order of business really is to execute which rights. We have a process running in a certain territory. I think that the fact that it's a first-in-class molecule and the data has been so strong, particularly in liver, makes it attractive in certain geographic areas where there's a high incidence with that particular therapeutic indication. On the other hand, there are folks within the U.S. who might find it additive to their efforts. We're also open to that. I would just say, as I indicated before, probably in the 6 or 12 months before we see some deals mature there. I think we're actively prosecuting that because we want to be ready when those data cards turn over to have those partners lined up for the pivotals. Great. I know, as you mentioned earlier, Denny, you've done a lot of deals, a lot of work to clean up the balance sheet. Maybe just talk about your current financial position and your current cash runway. Sure. We had $238 million on the balance sheet at the end of last quarter, which we were very happy with. There are a few things that we have to pay with respect to the legacy business and so on. We have cash through the end of next year. One thing I would remark, though, is that the cash through next year does not include earnout payments, which are two $37.5 million payments from Accord. That business is actually going very well. I think those folks are at about 31% market share. They're actually at a stronger market share than we were last summer. The transition of the legacy business to Accord is going well. The relationship is very positive. I think that we have good confidence that we'll get those earnout payments. That'll certainly help us as we go through next year and into 2027. Great. Is there anything that we haven't touched on yet today that you think we should talk about? I would just take a step back. When I think about the company, I think about our strength in execution. We have, I think, done very, very well in our commercial business all along. We've done very well developmentally. We've got a number of things approved. What gives me confidence as I look forward is, first of all, we have obviously very, very strong products, a very strong team. I think the way that we execute with the company is very, very positive. We're a small company, but we've been able to do things, I think, in a very effective manner and take it to the hoop. We'll continue to see that. Great. Maybe just in the last minute or so here, just to wrap up, to summarize, just the upcoming catalysts and why investors should be paying attention to Coherus over the next 6 to 12 months? I think first, the first catalyst, of course, is the data, as Theresa outlined with the clinical trials. I think we get into Q2 next year, we'll be turning over some cards. It gives, I think, fairly strong indications of how the products are working out. The mechanism of action gives us, I think, a significant degree of confidence that those will go in our direction. The CCR8, obviously, is going to be a very large opportunity. 2026 may be the year of CCR8 in our hands, but also in the hands of others. The second driver, I think, obviously, is the deals. We're working on those globally. I think we're very creative, and we're very strong collaborators. That's the next thing, I think, that you'll probably see: data and deals. Fantastic. All right. I think we're just about out of time. Thank you so much, Denny and Theresa, for being with us. Thank you for having us. Thanks, Colleen.