Welcome, everyone, once again to TD Cowen's 6th Annual Oncology Innovation Summit. My name is Mike Nedelcovych. I'm part of the large-cap pharma research team at TD Cowen, and I'm very pleased to welcome Denny Lanfear, the CEO of Coherus Oncology, and Dr. Teresa Lavallee, the Chief Development Officer. Denny and Teresa, thanks for joining us, and thanks for taking some time to tell us about Coherus's most recent efforts. Thank you, Michael. Thanks for having us today. Great. There is a lot of ground to cover, so we'll jump right in. We only have half an hour to do it. Maybe a more big-picture question, Denny, you could tell us a little bit about the recent transition that Coherus has effected. You all have, in impressive fashion, transformed into an innovative oncology company. Can you tell us a little bit about how you've achieved that, and what comes next? Thank you, Michael, and thanks for the question. I would say that we did it rather quickly. In the last year, we've done about $800 million all in with respect to our biosimilar divestitures as we refocus the company very sharply into innovative oncology. That entailed the divesting, of course, of our Lucentis biosimilar similarly, plus our Yusimry biosimilar, and lastly, of course, our Udenyca biosimilar. We were also able to pay off some $480 million of long-term debt and turn in our convertible loan, doing that while putting about $250 million on the balance sheet at transaction close, which we're very proud of. We shaped up the balance sheet, we redirected the company, and we now have the two very nice assets that Dr. Lavallee will talk to you about that are working their way through early to mid-stage clinical trials. In the broadest sense, though, what we're very happy about is our progress in expanding the potential indications for Loqtorzi. There we have a very cogent strategy, which is working out well. Number one, to put Loqtorzi in the hands of earlier-stage companies and assets so it's there when they get approved a few years later on. We've just announced a number one of those, and Teresa will talk to you about that. We also have pivotal trials that are going on with Loqtorzi in two additional indications. Lastly, of course, we have Loqtorzi together with our own pipeline of casdozokitug and our CHS-114. Loqtorzi is pretty much the first pillar of our strategy, and that's moving, as I said, quite well. Happy to talk about the ramp-up with respect to NPC and things like that. The second main thing, really, I think, is the CHS-114, our Treg depletor molecule. As you know, Tregs are an emerging superclass in biotech and oncology. We feel that we have a very well-positioned molecule with very high selectivity, and we're moving that into a number of indications. I think all the early data is very promising. Lastly, we're quite active in liver with casdozokitug, which has showed five complete responses in early-stage studies, working together with Loqtorzi, which is also very, very active in liver. We have a very well-integrated plan, I think, with respect to liver, which comprises the third pillar of our strategic trim variant as we go forward. Things, I think, are moving on pretty well. We did get all the deals done. We did get, I think, some very nice assets into the pipeline. Over the next 6 to 12 months, we'll be turning over our data cards, and we're looking forward to some promising results. Great. Let's stick on the topic of Loqtorzi. You mentioned the launch in nasopharyngeal carcinoma. How is that tracking relative to expectations? I think the first year moved along quite well. We had good growth quarter to quarter. Q4 also looked very good. However, I will say, though, that Q1 was a little flat by our expectations. That product is actually what you would consider promotionally sensitive. As you know, our Udenyca franchise had a supply interruption. The salesforce really found themselves focusing on that, interacting with customers who primarily were concerned if they were going to get their Udenyca allocations and so on in Q4 and even into Q1. To make matters even a little more complicated, we, of course, had to finish up the divestitures. The salesforce was wondering whether they were going to accord or staying in and so on while we reallocated the territories. I think there was a bit of a diversion strategically for the sales team in Q1. It was a bit flat, aggravated by a little overstocking, a little stocking of the inventory, I think. Coming out of Q2, we're seeing very good growth. We feel that we're getting back on the escalator there with respect to the growth. We're very confident that we'll be able to clip right along here now with our focus solely on that market, not sort of trying to do two things with the biosimilars. I would say also that with Loqtorzi, our focus, first of all, is to enhance the breadth, that is, the number of physicians prescribing, the number of practices, particularly into the community hospitals. Secondarily, to get depth of market penetration, that is to say that the next patient also that the physician sees with NPC goes on Loqtorzi. Lastly, the duration. We're focused there, making sure that those patients financially stay on the product and do not progress and see the maximum benefit. Breadth, depth, and duration. Lastly, I'd say we're focused really on making sure that doctors utilize the NCCN guidelines, which have just been very favorably revised to have us as the preferred treatment for first and second line, and understand that really that's to use Loqtorzi in conjunction with chemo. I think that gives us strong growth opportunities for the market going forward. Overall, I think a little blip there with Q1, a number of things going on, but as I said, I think we're back on track. Okay. In addition to nasopharyngeal carcinoma, you actually announced another partnership around Loqtorzi today. It is one of several, I believe, to potentially broaden the indication in the due course of time. Dr. Lavallee, maybe you could describe some of those partnerships and point out any of them. Yeah, Teresa's been a bit busy with these, Michael. Yeah. Oh, busy equals happy, right? Yeah, we're really excited about the opportunity to do combination clinical studies with a number of novel mechanisms. The one announced today, I think, really highlights this first-in-class molecule, STC-15, from Storm Therapeutics. This is a molecule that inhibits RNA methyltransferase activity of METTL3. It's the enzyme that's responsible for the methylation of the majority of N6 modification on messenger RNA. This is important for RNA stability, splicing, localization, and protein translation. It has a mechanism of anti-tumor effects, but also stimulates the innate immunity. It's a rational combination with a PD-1 inhibitor such as toripalimab. The STC-15 showed monotherapy activity in a couple of solid tumors, including non-small cell lung cancer in their first-in-human clinical study. The ability now to combine with PD-1 in cohorts of head and neck cancer and non-small cell lung cancer, as well as melanoma and endometrial cancer, is a very exciting opportunity. We look forward to the progression of that clinical study as first patient has been dosed and is open and actively enrolling. We'd say stay tuned for other announcements later this year for other novel mechanisms and tumor types that have been prioritized here at Coherus and really gets the breadth of toripalimab experience out in the U.S. and adds to our database of experience as well as activity. We are very excited about these opportunities to work with folks. Is the ultimate goal to drive toward potential label expansion with toripalimab as a backbone, I assume? Absolutely. It has both the advantage of advancing clinical development of toripalimab with these novel mechanisms to look for registration opportunities as the activity matures. It also gives us more data within the Western population to continue to show that toripalimab does not have regional effects and to be able to build up data sets that will support Coherus Oncology's trials as well. As we are developing in non-small cell lung cancer with casdozokitug, to continue to evaluate toripalimab in the disease helps build out experience and data sets with the activity of Tori there. The other point that I would make to dovetail on Dr. Lavallee's remarks, Michael, is that when we brought toripalimab in, we were very cognizant that it was differentiated, that it was a next-generation PD-1. It had shown activity subsequently in clinical trials, rather as not, particularly in low PD-L1 states, and actually is licensed for low PD-L1 in esophageal in the EU. We find it very gratifying that potential partners choose toripalimab as a next-generation PD-1 with its unique binding site and its high affinity and its high activity over the sort of first-generation MeToo products that are out there. We expect to see, of course, more of these transactions. Great. Let's talk a little bit about CHS-114. As you noted, this is a CCR8 targeting antibody that is intended to deplete Tregs. You presented some compelling clinical data at AACR just, I guess, a couple of months ago now. Boy, time flies. Maybe you could recap those data for us and point out what you think is most enticing about them. Sure. As Denny mentioned in his opening remarks, CHS-114 is a selective inhibitor of CCR8, which is a target that is preferentially expressed on tumor-resident Treg cells. While it has been well characterized that these Treg cells suppress immune responses in tumors, they are also important for normal homeostasis. Broad depletion of Treg cells can lead to autoimmunity. CCR8 has been an exciting target to identify to be able to preferentially target tumor-resident Treg cells. The target itself is a GPCR, a protein that is notoriously challenging to identify antibodies with selectivity. Our molecule is the only one that we have characterized or we have seen reported that has exclusive binding to CCR8. Any pharmacology that we are characterizing, we do not have to worry about off-target toxicity. We observed in the phase one clinical study a well-tolerated safety profile, dose proportionate PK. Importantly, at AACR, we were very excited to show at the pharmacologically active doses that we had immune activation with immune cytokines, but importantly, marked depletion of the Tregs in the tumor. We had between 52-97% depletion within the tumor biopsies. With that came a high infiltration of CD8 T cells. We have turned cold tumors hot, which has really been something that people have been looking for in the field because by having T cells in the tumor, they are now present and available for activation with things like PD-1 inhibitors or T cell engagers. A limitation for developing cell therapy like CAR-Ts in solid tumors has been getting them into the tumor. CHS-114 showing those biomarker changes really lends itself for combination. That proof of principle in the study we showed when we did the first seven patients in combination with toripalimab, these late-line treatment head and neck cancer patients. In a fourth-line patient, we had a dramatic partial response. Very early in the clinical study seeing that activity. We are very excited for looking forward. We are actively enrolling now second-line head and neck cancer patients, immediately after PD-1 progression, combination with toripalimab and CHS-114 to overcome that PD-1 resistance in a 40-patient cohort to look at activity and getting the recommended phase two dose with Project Optimus. We also have a study opening gastric cancer. Looking at the characterization, since this is a targeted therapy, looking across solid tumors, there's a large number of solid tumors that have a high density and prevalence of CCR8-positive Tregs, including colorectal, breast cancer, non-small cell lung cancer, esophageal squamous cell carcinoma, and a variety of others. We're actively looking at internally other tumor types to add to our protocols. You've done a lot of work profiling the competitive landscape here, including through some internal experiments. Maybe you could recap for us what you found, how CHS-114 performs relative to competitor molecules. Yes. We have the required potency on the molecule. As I said, one of the things that we noted early on is the challenge in getting a selective molecule. In our lead identification screen, as you do antibody discovery, you look through a wide number of antibodies to identify the lead candidate to take into the clinic. Typically, you get a large number of them that only bind your target, have the required potency and selectivity. Quite uniquely for CHS-114, we only found one and only one that uniquely bound CCR8, so no off-target. When we profiled three competitor programs, they all had off-target binding, including one of them binding J-chain, which is a protein that's abundantly expressed in the gut. I'd worry about gut toxicity with that molecule. We did see a report at SITC from one of the Chinese programs last year that identified toxicities that we're not observing in our program. I think that we're seeing some of that bear out in the clinic where they're having limitations based on the safety profile. Got it. That's helpful context. I think folks in the investor community, myself included, sometimes struggle interpreting early-stage oncology data from small data sets, especially when of necessity there's not a control arm, at least yet, and especially when it's a combination trial. So the CHS-114 plus toripalimab data are tough to interpret from the efficacy side. What gives you confidence in bringing it forward? Is it more the totality of the data, or should we really be honing in on that one response as a source of support? It's always the totality of the data. I think the safety one, very importantly, the whole thesis with CCR8 is that it would selectively deplete Tregs in the tumor. Seeing that is phenomenal because every other attempt to target Tregs has caused toxicity. We've even seen that with TIGIT, if we remember the discussions between FC competent or not, because they wanted to deplete Tregs and then in late-stage clinical trials running into toxicity. The biopsy data, I also would say, is very exciting seeing that large infiltration of CD8 T cells was not expected. I find that very exciting and really sets it up well for combination with other agents to turn on the immune system. We know that targeted therapies often give you a very strong response, but it doesn't have the duration of response. The advantages of activating the immune system is you get long-term duration, which translates to survival, which is the regulatory endpoint. Seeing a response in a refractory patient that had progressed on PD-1 and every other available therapy, a fourth-line patient responding, is incredibly exciting. We have the study design now to look for that activity. As we're going into the PD-1 refractory setting, I think that showing, particularly when we have PD-L1 low, PD-1 progressed tumors, that gives you a confidence that the PD-1 would not contribute significantly to the activity or meaningfully. As we get the activity in the next cohorts, we would go into randomized studies. Got it. Let's talk about Casozo-Keytoog. Theresa, maybe you could give us a quick recap of what this molecule is and what its intended use is at a molecular level, and then we could talk about its development program. Sure. It is an antibody against the IL-27 cytokine, so an antagonistic antibody to inhibit the cytokine. It is well understood in inflammatory diseases. There are a number of approved antibodies in the IL-27 family showing that you can rebalance the immune system by inhibiting a cytokine. This is a first demonstration in oncology with a good safety profile lending itself to combinations. Inhibiting a single cytokine has shown immune activation in cancer patients and, importantly, monotherapy responses in tumor types that the preclinical models told us should work. Cytokines are context-dependent, and all of the preclinical studies have said that the lung and liver tissue is particularly important areas where IL-27 has immune suppressive phenotype. Seeing monotherapy responses in lung cancer and this activity in liver cancer has us incredibly excited in what Denny mentioned in his opening remarks. Whereas in a phase two study, 30 patients, we saw numerically higher activity in combination with atezolizumab and bevacizumab than atezolizumab and bevacizumab alone. I think what really stood out is while the overall response rate of 38% and the PFS of 8.1 months is numerically higher than what's been reported, the 17% CR rate, it really stands out. If you look across phase three studies in first-line HCC, none of them approached 10% CR rate. The highest reported that I'm aware of is 8%. To see a 17% CR rate is really a standout activity and really speaks to the biology of IL-27 being important in dampening the immune response. Inhibiting it allows for that stronger activity. We have a randomized study with Tori Bev, casdozokitug versus Tori Bev ongoing now. That randomized data will show that addition of Casozo and what that activity brings. That is enrolling this year. We are also looking to progress with a cooperative group the activity of Casozo in squamous lung. Got it. So the development path from here for Casozo, when might we see those liver data? Is that a 2026 event or later? What's the next step for the lung cancer trials? We anticipate enrolling the HCC study this year, so data next year. For the lung cancer study, we've had interest from a cooperative group based on the strong clinical activity we've seen to date. It's in the planning stages. I think the formal announcement of that study opening and progressing would be the next milestone. Okay. Denny, if I can editorialize a bit, it seemed as though you were emphasizing the liver cancer indication for Casozo in your opening remarks. Should that be the focus in our minds for Casozo, or was that just because those data are fresher off the press? I think getting five complete responses, it is such a startlingly positive result. It's hard not to really look at that as one of the profound accomplishments in the last 12 months with respect to the pipeline. We look forward to the Tori Bev data with it, but I think we're just very, I wouldn't say confident, but we're very hopeful that the patient benefit will continue to read out. I think the, as Theresa indicated, I think the lung will take a little longer. It'd be a larger study in the hands of a cooperative, but ultimately we'll see how that goes. Certainly, the liver is doing, the liver with Casozo is doing very well here early on and very consistent with its MOA. Okay. Great. A lot to look forward to in the next 12 months then. Denny, in our final minute, I do not know if you have any closing remarks or if there is anything in your pipeline that we failed to talk about that you would like to highlight. No, I think we covered the pipeline. I guess the closing remark that I would say is that the company established a very strong track record previously with respect to development, regulatory affairs, and commercial. We are the best in the business there in each of those environments. I'm particularly proud of how well we did in commercial, and that gives me really great confidence in with the commercial story as we move into Loqtorzi and NPC and beyond. You'll also see us focusing on execution, which is something that the company, I think, does very well. Theresa and her team, I think, really do an excellent job of, first of all, strategizing the development programs, but secondarily, bringing in the fruition and then bringing the results forward. All very positive for us as we focus on the execution. That's what you'll see from us. Great. We look forward to it. Thanks so much to Denny and Theresa and the Coherus team for your time and for everyone on the line. Thank you. See you around, Michael. Bye-bye. Bye-bye.