Coherus at The Citizens JMP Life Sciences: Strategic Oncology Focus

On Thursday, 08 May 2025, Coherus BioSciences (NASDAQ:CHRS) unveiled its strategic focus on oncology at The Citizens JMP Life Sciences Conference 2025. The company, soon to be rebranded as Coherus Oncology, spotlighted its flagship drug Toripalimab (Loqtorzi) for nasopharyngeal cancer and detailed its innovative development strategy. While positive about its financial restructuring and growth potential, Coherus also faces the challenge of meeting ambitious revenue targets.

Key Takeaways

• Coherus is transitioning to Coherus Oncology, emphasizing its focus on oncology.
• Toripalimab (Loqtorzi) is central to the company’s strategy, targeting nasopharyngeal cancer.
• The company divested UDENYCA for $575 million upfront, reducing debt and boosting cash reserves.
• Coherus aims to achieve $150-200 million in annual revenue from Loqtorzi within three years.
• Clinical trials for pipeline assets like CHS-114 and Casdozo are advancing, with data expected next year.

Financial Results

• UDENYCA Divestiture:

- Sold for $575 million upfront, with a potential $225 million earn-out.

- Total possible value: $800 million.

• Debt Repayment:

- Approximately $500 million in debt was paid off using divestiture proceeds.

• Cash Position:

- $250 million added to the balance sheet post-deal closure.

Operational Updates

• Loqtorzi Launch:

- Launch is proceeding as expected in nasopharyngeal cancer.

- Focused on increasing breadth (more institutions, doctors) and depth (more prescriptions per doctor).

- Monitoring therapy duration as a key revenue driver.

• Clinical Programs:

- CCR8: Project Optimus fully enrolling with 40 patients; expects data early next year to set up for Phase 2.

- Casdozo: Combination study with toripalumab and bevacizumab in frontline liver cancer fully enrolling this year for data readouts next year.

Future Outlook

• Loqtorzi:

- Aiming to increase revenue to $150-200 million annually within three years.

• CCR8 Program (CHS-114):

- Awaits further efficacy data, anticipates data early next year to set up for Phase 2.

- Go/No-Go hurdle: Objective response rates around 20% with PFS around nine months in second-line head and neck cancer.

• Casdozo (Anti-IL-27):

- Awaits randomized study in liver cancer to read out next year.

- Go/No-Go hurdle: Aiming to repeat the CR rate in the 15% above range in frontline liver cancer with the current randomized study.

Q&A Highlights

• CCR8 Differentiation:

- Their antibody (CHS-114) is highly selective for CCR8 with no off-target binding, unlike competitors.

- Safety: Dosed to 1200 mg in phase 1 with no toxicity; further combination doses are being tested.

- Indication: Pursuing head and neck cancer market.

• Casdozo Development:

- CR Rate goal: Repeating the complete response rate in the 15% or higher range would warrant a pivotal study.

• UDENYCA Divestiture:

- Divested to focus on innovative oncology.

- $575 million upfront and a possible $225 million earn-out.

• Market Dynamics:

- No real standard of care when Loqtorzi entered the market.

- Aiming to replace chemo and off-label PD-1 drugs.

In conclusion, Coherus BioSciences is steering its strategic focus toward oncology, leveraging its financial restructuring to advance its pipeline. For more details, refer to the full transcript below.

Full transcript - The Citizens JMP Life Sciences Conference 2025:

Unidentified speaker, Host: So welcome. Good morning. This is the second day of the Citizens Life Science Conference, and it’s my pleasure to introduce the next company, Coherus Biosciences.

Here for Coherus is, Denny Lemfier, CEO, and Theresa, Lavelle, chief scientific officer and development officer. New title today. Welcome, guys. Appreciate you coming. So I never know exactly who’s in the audience or who’s listening to, the webcast, and so would love to, maybe have you guys spend four or five minutes on just giving us an overview of what Coherus is about before we dive into some questions.

Denny Lemfier, CEO, Coherus Biosciences: Sure. Well, first of all, thank you very much for your kind invitation, to the conference and the opportunity today to to talk about our company, Coherest Biosciences. Soon to be Coherest Oncology, I would add consistent with our focus now on innovative oncology. So, let me start first of all, with our foundational asset, Torpalimab, a brand name Lactorsi. This was a very deliberate attempt when we began moving towards innovative oncology to bring in a PD-one.

We thought that if, if you’re going to be a major player in, innovative oncology, you need your own proprietary PD-one. We screened, over a dozen different assets across the world. And in particular, we became very focused on Toropalumab because it had been developed, very uniquely as a next generation product, with a focus on the FG loop as the epitope. And this provides Toropalumab with some significant differentiation which has been demonstrated across a number of tumor types, including the esophageal where it is active in the low PD L1 state, which is really very interesting and very rare. So when you bind the FG epitope of PD-one on the T cell, secondarily what occurs then is internalization of the PD-one and then there is a very different set of signaling which occurs around chip two, which doctor Levali can give you greater, illustration on.

But we brought that forward, and then we focused on getting it approved. COVID of course hit, but, we are proud to say we were the first PD one approved, on Chinese data and we are now in, recurrent metastatic nasopharyngeal cancer. We are the only product that is approved across, all lines of that. And, we have very good positioning on the NCCN guidelines. We are the only preferred treatment across all that.

And this has established Loktorzi as the standard of care in nasopharyngeal cancer. We got that product launched last year and we’re happy to talk about that in a little more detail how that launch is proceeding and how we are progressing with respect to both the breadth of the healthcare providers and also the depth getting re upped as far as the scripts and so forth duration of therapy. But Toropalumab has a very elegant development strategy here at Coherus developed by Teresa And that is to develop in combination in three different ways. First of all, of course, with our own pipeline, Casdos, Zoketo, again our CCR8, which we’ll talk about secondarily. But also in the hands, of others where we provide the product, we will supply the product, but they will do the pivotal trials and all the trials at their cost.

So we currently have a few of these, going on. Our partner Jun Shi has Toropalumab in a pivotal with BTLA in small cell cancer. They’re also pursuing another Chinese study in first line liver with the background of libatinib and so on. And we also have our partner Inovo who’s moving forward with a pivotal indication later this year. We have a number of partnerships that we have done with respect to our Palmed.

And our strategy when we put the product forward was that we would proliferate it into the environment. We would do a number of deals with others. And that way, we would be the second generation PD one of choice as Keytruda came off patent in 2028, and so on. The the strategy of co developing Toropalumab as a proprietary PD one in conjunction with our own pipeline I think is a very elegant one. And that you get sales multiples for having two assets on the label when you go forward.

And as I said, Teresa will talk to you a little bit about how we’re doing with Casdozo and CCRA. So, secondarily, those two assets I think are very very interesting. We have recently put forward some very interesting data, AACR and CCRA. Our view is that the CCR8 class, the anti Treg class, is an emerging mega class really within pharma and there’s a number of folks of course that are in that class and moving forward. But we are the first to have US patient data and we had very very nice biomarker data and scans that we put forward.

The class is very interesting primarily because Tregs play a pivotal role in the tumor microenvironment in preventing CD8 plus T cells from attacking the tumor. And so people for a long time have sought to be able to remove Tregs in the tumor microenvironment selectively and thereby increase, the activity of T cells. As I said, Theresa can walk you through some interesting data. Our our second big asset with our pipeline is casdozo ketog. It’s an anti IL twenty seven.

And that asset we’re very pumped up on, very very positive. We have done a study in first line liver with cas dozo ketog on the background therapy and have shown five complete responses across twenty seven patients for seventeen-eighteen percent response rate which is really very very extraordinary and really shows both the promise of the biology but also how we are going to move this forward in a very holistic fashion, in liver going forward. So we have a great PD-one moving forward in the market. We have an excellent combination strategy with both our own proprietary assets which are proving out in the clinic. And also we’re moving out for more broadly partnering with others with Toropalumab.

And I would just let Teresa offer a few other comments about some of the other things that we have planned to do with respect to the pipeline.

Theresa Lavelle, Chief Scientific Officer and Development Officer, Coherus Biosciences: Yeah, now I think the key for Coherence is when we look at our pipeline is looking for agents that have a strong line of sight. So one of the challenges in the field with immuno oncology is who to treat. So if you have to do 15 phase IIs to figure out where there’s a signal, it’s a big spend with a long not as good return. So understanding with casdos at ketog that the mouse data showed us that lung and liver were very specialized tissues for this immune regulatory cytokine. So only seeing activity in those tissues and then having it go into clinic and see monotherapy responses in lung cancer.

And then this impressive CR rate that is unprecedented in liver cancer really sets that up for a focused development. Likewise, CCR8 is that preferentially targeted tumor Treg agent and seeing a partial response in head and neck cancer, a tumor type where the majority of Tregs, over 75%, express CCR8 and a high density really gives that early proof of principle to give us excitement. And as Denny mentioned, we have nasopharyngeal carcinoma for Torapalumab as The US label, so broadening its use in head and neck is a really exciting opportunity for us.

Unidentified speaker, Host: So let’s dive a little bit more into some of the data you had at ACR. CHS one one fourteen, how does this differentiate? Right? So so CCR eight, like as a target, right, has been I believe it’s been sought after, You know, I’d love to kind of know how you differentiate from kind of what’s out there. And then maybe more importantly for our listeners, as we think about the head and neck landscape, right, and the other players that, you know, are are are kind of dominating the headlines, right, whether it’s MERS or Vicara, how do you guys plan on kind of threading the the needle there with your asset?

Theresa Lavelle, Chief Scientific Officer and Development Officer, Coherus Biosciences: Yeah. So to start, so CCR eight was identified with single cell analysis, And people have tried a variety of targets for T regulatory cells. It’s not a new concept getting rid of the immune suppressive cell. The problem is Tregs are important for homeostasis. So if you take out too many Tregs, you get autoimmunity.

And then Treg is a subset of a CD4 T cell, so not taking out normal CD4s or CD8s has been a challenge. That was the problem with CCR4, for example. So single cell analysis of tumor resident Tregs identified this upregulation of this target. And so as that’s really come forward, there’s a number of players who have developed a fucosylated antibody, so it’s a bind and kill mechanism. The challenge with GPCRs is that it’s a protein that doesn’t have a lot on the exterior of the cell.

So while there are hundreds of small molecules approved on GPCRs, there’s only a handful of antibodies because getting selectivity is a challenge. So from the screens that we did, there’s one and only one antibody that exclusively binds CCR8 that is very unique in an antibody lead identification campaign where you only have one that’s selective. When we profiled three competitor programs, we found they all have off target binding, including one of the programs having J chain binding. And so what does that mean? I worry about GI toxicity if you buy J chain.

And we’ve heard chatter in the field. There hasn’t been a lot of data disclosures of toxicity with some programs. There was a presentation at SITC from a Chinese program, Kualu, with their QLP molecule, and they had dose limiting toxicity about the midpoint, around five forty mg, suggesting that that could be an off target issue. So our program is highly selective. We were able to dose up to twelve hundred milligrams in phase one without toxicity and then really move it forward now with two other dose levels that are lower than that in combination with Torapalumab.

At AACR, we showed safety with that combination, as well as in seven patients with the combination, we had a PR at the highest dose level. So really excited about that. In terms of Baqara and MERIS, I mean, think what’s really exciting in the field is this real demonstration that two targets are better than one. So the eGFR plus something me better is really a breakthrough in head and neck, which has really been a patient population that’s highly underserved for decades. The EGFR space is a mechanism that will really benefit patients, but there are still opportunities in the second line and later for other treatments.

And then eventually targeting Tregs with that could also be of interest. So we think that there’s room to have orthogonal approaches. This is tried and true across oncology and we love the fact that these bispecifics are really showing that you get synergy, that it’s not just additive benefit.

Denny Lemfier, CEO, Coherus Biosciences: This complementarity, of mechanism of action I think is really powerful. And one of the key things I think that’s going to drive the CCRA class forward in the coming years as really, I think there may be just a gold rush as people just go after these products.

Unidentified speaker, Host: Got it. As we think about the next development steps, right, when do we get the next set of data, about how many patients, and I think most importantly as you look at this data objectively, what kind of constitutes your of go or no go hurdle that you’d like to be?

Theresa Lavelle, Chief Scientific Officer and Development Officer, Coherus Biosciences: Yeah, so we am thrilled that we were able to show the critical parameters at AACR. So one of the aspects in development that I think is not as appreciated for time and money and risk as your recommended phase two dose, particularly with Project Optimus. So we showed in the poster the two doses that we’re advancing are pharmacologically active. We saw greater than 50% Treg depletion in the tumor at both dose levels. And that’s important because preclinical work showed that you had to decrease at least 50% to get activity.

So all doses was fifty two to 97% depletion. The other exciting part that was underappreciated was the increase in CD8 T cells. So the tumor’s really lit up, really sending it for a PD-one combination, but also thinking about partnerships with T cell engagers. You know, this is an opportunity where you need T cells in proximity in the tumor to have activity. So it lends itself to new combinations.

So we will fully enroll. I said we had the safety cohort with Torapalumab. Now we’re doing the full Project OPTIMISS 40 patients at the two doses. We hope to show further efficacy as well as a recommended phase two dose from head and neck and gastric cancer early next year to really set us up to advance this agent. To seeing that activity so early is really exciting.

And then from the casdozo program is enrolling now. We have the combination with toripalumab, casdozobevacizumab in frontline liver cancer in a randomized study. So having that fully enrolled this year for data readouts next year is really what we’re excited about.

Unidentified speaker, Host: So for both programs now, since we’ve touched on both, what do you think, I mean, for you guys to advance the products forward, but also for investors to kind of pay attention to? What do you what would you kind of say is your bogey that you want to hit in terms of objective response rates or maybe even PFS or duration of response?

Theresa Lavelle, Chief Scientific Officer and Development Officer, Coherus Biosciences: Yes, I think that hitting the benchmarks in the second line head and neck space, really looking that in the 20% ORR with a PFS, you know, the nine month mark would be really exciting to really advance it. And looking at the patients at the two doses to really get into, is that enough data to set it up for the next study that could be with pivotal intent. And then for the casdozo, I think repeating that CR rate in the fifteen percent above range would really set it up for a pivotal study.

Unidentified speaker, Host: So switching to casdozer real quickly, you know, would love to kind of understand its potential. You had some data at ASCO GI, maybe just very quickly, mentioned the CRs, you know, are the CRs still ongoing? Will we get an update on those patients? But I think even more importantly in this environment right like trying to harness the power of cytokines has been you know a challenge right at best for many, many years, and we’ve been following this space. Why do you think something like casidozo is likely going to get to the finish line?

Theresa Lavelle, Chief Scientific Officer and Development Officer, Coherus Biosciences: Yeah, I mean I think of, we think in therapeutic areas, so from an immunology standpoint, cytokines are validated, particularly the IL-twelve, IL-twenty three, IL-twenty seven family. So it’s a cytokine that’s proven to rebalance the immune system. I think and the honest answer is I wasn’t enthusiastic about this program when I got started because I’ve seen so many failures in oncology. Human data is the the the aspects that really takes us forward. We’re in a data driven way to show that inhibiting a cytokine in cancer patients can rebalance the immune system.

We had beautiful dose dependent effects. Not until we showed full inhibition of IL-twenty seven did we see that T and NK cell activation. The other aspect that I think it goes back, I mean, it’s been, I mean, Ren and I have known each other for decades. My frustration in this field is people don’t pay attention to who to treat. You don’t just go after, oh, this is the big market.

You’ve got to follow the science. The fact that the mouse showed us that there was activity in lung and liver, three different preclinical models in liver cancer, if you do a standard ectopic sub q tumor model, there’s no activity. It has to be in the right tumor microenvironment than to see that translation and see those responses in the clinic exactly where it’s supposed to be. So it may not be I mean, we think we have hypotheses about other tumor types where it could make sense, but we’re laser focused on where the mouse, where the biology is said, and the clinical data are there. So if the clinical data didn’t really translate, we wouldn’t advance the program.

But again, that CR rate is different than anything that’s been seen, so the relative contribution of castosacitag is clear.

Unidentified speaker, Host: So do we have an expectation for updated data later this year, or is everything kind of on randomized side for next year?

Theresa Lavelle, Chief Scientific Officer and Development Officer, Coherus Biosciences: Yeah, so we have to enroll this study and have it read out. So that will be next year.

Unidentified speaker, Host: Excellent. So I want to switch gears very quickly to your p one inhibitor, right, and kind of how things are going as far as the launch is concerned. Because you’re in a very unique position within the biotech world. You have a product, we’ll get to the cash position because I think the audience would be very interested in that as well. But maybe right now just starting off, how is that launch going?

You know, where do you think it could ultimately, go as far as, market potential total addressable market?

Denny Lemfier, CEO, Coherus Biosciences: The launch is going consistent with our expectations. This is a is a rare disease, so there’s 2,000 of these patients out there. So they have to show up at the doctor, you know, every two or three years a doctor sees a patient. There was no real, standard of care. There wasn’t anything approved.

People were using chemo or they’re using off label PD ones like Keytruda or whatever. So there’s an educational process that we’ve embraced for the first year with the product. But we we have an absolutely terrific label and super compelling data. The data I would I would add is so compelling, that the the NCCN committee actually met off cycle and moved it to the the top of the guidelines. We are the only preferred first line in this disease.

So that’s very powerful when you approach a doctor and you start illustrating to them, hey, you know, you can’t just do chemo, you need to do chemo plus, Loktorzi to benefit your patients. That said, the patients currently are being treated either simply with chemotherapy or some people with an off label PD-one and then Lactorsi. So we’re focused very sharply on that particularly with patients that are on chemo where our label allows us to add Lactorsi to that. So that’s one part where we’re getting significant growth. We are focused on increasing the breadth of our efforts, getting more institutions and more doctors.

Those efforts are very focused now with our commercial team just focused only on Lactorsi and also not looking Lactorsi plus our former biosimilar assets. The second is depth. Alright? That means that the doctor writes one script, the next patient shows up, writes another script. And we’re doing very, very well with that.

That’s growing, very consistently. And lastly, revenues will be driven by how long the patients stay on therapy, duration of therapy. Right? So you want those patients to stay on until they progress for an extended period of time. And that is also marching up very nicely.

So, we’re very focused on, putting Lactorsi on the escalator as I as I like to say. And that’s I I think that’s moving along, pretty well. And and it’s a rare, you know, it’s a rare, oncology disease. You know, how many patients? What do

Unidentified speaker, Host: you think the the market potential is?

Denny Lemfier, CEO, Coherus Biosciences: Well, it’s it’s about 2,000 patients and we can, get to, you know, almost all of them. There’s about, 4,000 physicians that we have to get to. We are staffed to do that, with our team. The way we view Lactorsi though, it’s you know, it is I wouldn’t I won’t represent to you that it’s a giant product, but but for us, it’s very it’s very significant in so far as, it will offset a lot of our development costs. After we get past, for example, about 15,000,000 a quarter, the sales force and all the promotional teams will have been paid for.

And after that, it’ll start to pay for some of the, you know, the s g and a, the clinical trials, and other things all the way up. We we we feel fairly confident that we’ll we’ll march it up to a hundred and 50 to 2 hundred million a year, and that’ll probably be three years out.

Unidentified speaker, Host: Excellent. And and Denny’s no stranger to actually selling drugs. This is actually pretty unique as well. You know, you’ve you have a background in this. Actually, UDENYCA, one of the drugs at Coherest Bio Sciences before it’s becoming Coherence Oncology had, has been divested.

This was also sold. Can you just tell us a little bit about that? How much you sold it for? And kind of in the last minute and a half we have, what kind of cash position you have once you

Denny Lemfier, CEO, Coherus Biosciences: so I you know, I really love that product. It, you know, I we’re the very first biosimilar company in The US, and I’m a I’m a huge Star Trek fan. So, you know, the the product number for UDENYCO was 17 o one, which is, of course, the number of the whole of the Starship Enterprise. And so to put it to go where no man had gone before, right, biosimilars. And so we we went and did that.

We’re very happy with that, But it was time to take that product and put it in the hands of a team who was really going to expand that globally and and take it into The US to even larger market share than we are able to do. The biosimilar business is a great business. We did better than anybody else at very very strong execution commercially. But our focus always as a company has been on patient benefit. And the ability to have a small, nimble, highly effective, innovative oncology company that’s able to extend the life and the survival of cancer patients is a passion my team and I all share.

And so I we we have served the health care system with the biosimilars and savings. But, innovative oncology is an area where as a small company you can really deliver disproportionate benefit to your patients and to your shareholders who come along with you. And I and I think that is a very noble cause.

Unidentified speaker, Host: How much was the how much were you able to sell this for and what’s your cash position?

Denny Lemfier, CEO, Coherus Biosciences: Yeah. I think we sold it I think we sold it for more than people expected we sold it for. You know, I I probably could have got a little more for it if I hadn’t had a supply interruption in the middle of the process, which, of course, generate a little tap dancing here and there. But we did, I think, $5.58, 75 millions on the backside with an earn out. We feel very confident that we’ll, that we’ll get that those those goals within reach.

We are able with these sets of transactions that we’ve done over the last twelve months, which I think totals about $800,000,000 in, divestitures on a market cap of maybe a hundred and $50,000,000. We are able to pay off almost $500,000,000 in debt and drop $250,000,000 into the balance sheet post deal close. So that’s that’s where we sat the the day the deal closed. You know, a very nice cash balance. We’ve got a couple years of runway there.

Certainly time for a doctor Vali here to turn over her data cards and and show how things are going. So I’m I’m extremely pleased with the outcome and, I’m, you know, and I’m very proud about our execution. You know, Coriros is a company that’s been, you know, through COVID, you know, yin yangs with the regulators and all sorts of other things. But we really pride ourselves on our execution, whether that be our development execution, you know, where we’ve done well, our regulatory execution where we’ve gotten numerous approvals, or our commercial execution where we were the, the class leader in biosimilars in Medicare Part B. And now we’re going to go ahead and do it again with these Casdozo and these other assets in Lactorsi.

Unidentified speaker, Host: Thank you very much. We look forward to following Coherence Oncology going

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