Coherus BioSciences at 6th Annual Oncology Summit: Strategic Shift to Innovation

On Tuesday, 27 May 2025, Coherus BioSciences (NASDAQ:CHRS) participated in the 6th Annual Oncology Innovation Summit. The company highlighted its strategic transformation from a biosimilar focus to a pioneering force in oncology. This shift, marked by significant financial restructuring and promising pipeline developments, aims to position Coherus as a competitive player in the oncology sector.

Key Takeaways

• Coherus divested its biosimilar portfolio for $800 million, paying off $480 million in debt and securing $250 million in cash.
• The company is focusing on innovative oncology assets, including Loktorzi, CHS-114, and casdozoketog.
• Loktorzi’s sales were flat in Q1 due to external factors, but growth is expected in Q2.
• CHS-114 and casdozoketog show promising early clinical data, with potential for further development.
• Strategic partnerships are expanding Loktorzi’s indications and market reach.

Financial Results

• Coherus completed divestitures totaling approximately $800 million.
• Paid off $480 million in long-term debt, strengthening the balance sheet.
• Secured $250 million in cash post-divestiture transactions.
• Q1 Loktorzi sales were flat due to UDENYCA supply issues and divestiture distractions.
• Anticipated growth in Q2 as Loktorzi sales regain momentum.

Operational Updates

Loktorzi (Toripalimab)

• Focus on increasing Loktorzi’s market penetration and patient persistence.
• NCCN guidelines now recommend Loktorzi for first and second-line nasopharyngeal carcinoma.
• Partnership with Storm Therapeutics to explore Loktorzi in various cancers.
• Multiple partnerships aim to broaden Loktorzi’s indications.

CHS-114 (Treg Depleter)

• Early data indicates 52-97% Treg depletion and immune activation.
• Combination study with Toripalimab shows partial responses in late-line cancer patients.
• Studies underway for second-line head and neck cancer and gastric cancer.
• CHS-114 exhibits exclusive binding to CCR8, unlike competitor molecules.

Casdozoketog (Anti-IL-27 Antibody)

• Phase two study shows 17% complete response rate in liver cancer.
• Ongoing randomized study with Toripalimab and bevacizumab.
• Potential development in squamous lung cancer is being planned.

Future Outlook

• Casdozoketog’s HCC study enrollment is expected this year with data anticipated next year.
• Lung cancer study is in the planning stages.
• Coherus aims to focus on execution in development, regulatory affairs, and commercialization.
• Data releases expected over the next 6-12 months.

Q&A Highlights

• Discussion on transition from biosimilar to innovative oncology company.
• Questions about Loktorzi’s launch and its market performance.
• Inquiries about partnerships and expansion of Loktorzi’s indications.
• Exploration of CHS-114 and casdozoketog’s development programs.

Readers are encouraged to refer to the full transcript for a comprehensive understanding of Coherus BioSciences’ strategic direction and developments.

Full transcript - 6th Annual Oncology Innovation Summit:

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Well, welcome everyone once again to TD Cowen’s sixth annual oncology innovation summit. My name is Mike Nadelkovich. I’m part of the large cap pharma research team at TD Cowen, and I’m very pleased to welcome Denny Lanphier, the CEO of Coherus Biosciences, and doctor Theresa Lavalet, the chief development officer. Denny and Teresa, thanks for joining us, and thanks for taking some time to tell us about Coherus’ most recent efforts.

Denny Lanphier, CEO, Coherus Biosciences: Thank you, Michael. Thanks for having us today.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Great. Well, there’s a lot of ground to cover, so we’ll jump right in. We only have half an hour to do it. Maybe more big picture question. Then you could tell us a little bit about the recent transition that Coherus has affected.

You all have in in impressive fashion transformed into an innovative oncology company. Can you tell us a little bit about how you’ve achieved that and and what comes next?

Denny Lanphier, CEO, Coherus Biosciences: Well, thank you, Michael, and and thanks for the question. Well, I would say that we did it rather quickly. In the last year, we’ve done about $800,000,000 all in with respect to our biosimilar divestitures as we refocus the company very sharply into innovative oncology. So that entailed the divesting, of course, our Lucentis biosimilar similarly, plus our Yosemir biosimilar and lastly, of course, our UDENYCA biosimilar. We’re also able to pay off some $480,000,000 of long term debt and turning our convertible loan doing that while putting about $250,000,000 on the balance sheet at transaction close, which we’re very proud of.

So we shaped up the balance sheet, we redirected the company and we now have the two very nice assets that Doctor. Lavalli will talk to you about that are working on their way through early to mid stage clinical trials. In broadest sense though, what we’re very happy about is our progress in expanding the potential indications for Loktorzi. So there we have a very cogent strategy, which is working out well. Number one, to put Loktorzi 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 Theresa will talk to you about that. We also have pivotal trials that are going on with Lactorsi and two additional indications. And and lastly, of course, we have a Lacturizy together with our own pipeline of cassocatib and our Treg one one four. So Lacturizy is very pretty much the first pillar of our strategy, and that’s moving, as I say, quite well.

Happy to talk about, like, the ramp up with respect to NPC and things like that. But the second main thing really, I think, is the CHS one one four, our Treg depleter molecule. And as you know, Tregs are an emerging superclass in biotech and oncology. We feel that we have a very well positioned molecule, very high selectivity, and we’re moving that into a number of indications. And I think all the early data is very promising.

And then lastly, we’re quite active in liver with casdozoketog, which has showed five complete responses in early stage studies working together with lactorzi, which is also very, very active in liver. So we have a very well integrated plan, I think with respect to liver, which comprises the third pillar of our our strategic, Tremvirate as we go forward. So 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.

And over the next, six to twelve months, we’ll be turning over our data cards and we’re looking forward to some promising results.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Great. Well, let’s stick on the topic of Loktorzi. You mentioned the launch of nasopharyngeal carcinoma. How is that tracking relative to expectations?

Denny Lanphier, CEO, Coherus Biosciences: Well, 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.

And as you know, our UDENYCA franchise had a supply interruption. So the Salesforce really found themselves focusing on that, interacting with customers who primarily were concerned if they were gonna get their UDENYCA allocations and so on in q four and even, into q one. That we then to make matters even a lot more complicated, we, of course, had to finish up the divestitures. So then we have the Salesforce wondering whether they’re going to accord or staying in and so on while we reallocated the territories. So I, you know, I think there was a bit of a diversion strategically for the sales team in in one.

It was a bit flat, aggravated by a little over overstocking, a little stocking of the inventory, I think. But coming out of q two, 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, you know, with our focus solely on that market, not sort of trying to do two things with the biosimilars. I I would say also that with, Torzi, 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 MPC goes on like Torzee. And lastly, the duration. So we’re focused there, making sure that those patients financially stay on the product and do not progress and see the maximum benefit. So breadth, depth, and duration. And 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 should use lactorzine conjunction with chemo.

And I think that gives us strong growth opportunities for the market, going forward. So overall, I I think a little blip there with q one, number of things going on. But I as I said, I think we’re back on track.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Okay. Well, in addition to nasopharyngeal carcinoma, you actually announced another partnership around Loktorzi today. It’s one of several, I believe, to potentially broaden the indication, in the due course of time. Doctor Lavelle, maybe you could describe some of those partnerships and point out

Denny Lanphier, CEO, Coherus Biosciences: You’re gonna Teresa’s been busy with these, Michael. Yeah. Oh, busy equals happier.

Theresa Lavalet, Chief Development Officer, Coherus Biosciences: Yeah. We’re really excited about the opportunity to do combination clinical studies with a number of novel mechanisms. And 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 METL three. It’s the enzyme that’s responsible for the methylation of the majority of modification on messenger RNA.

And this is important for RNA stability, splicing, localization, and protein translation. So it has mechanism of antitumor effects, but also stimulates the innate immunity. So it’s a rational combination with a PD-one inhibitor such as Torapalumab. The S STC15 showed monotherapy activity in a couple of solid tumors, including non small cell lung cancer in their first in human clinical study. So the ability now to combine with PD1 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.

And 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 Torapalumab experience out in the in The US and adds to our database of of experience as well as activity. So we’re very excited about these opportunities to work with folks.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Is is the ultimate goal to drive toward potential label expansion with Torapalumab as a backbone, I I assume?

Theresa Lavalet, Chief Development Officer, Coherus Biosciences: Absolutely. So it has both the advantage of getting advancing clinical development of Torapalumab with these novel mechanisms to look for registration opportunities as the activity matures. It also gives us more data within the Western Western population to continue to show that Toropalimab doesn’t have regional effects and to be able to build up data sets that will support co heresis trials as well. So as we’re developing in non small cell lung cancer with casdosa ketog to continue to evaluate Toropalimab in the disease helps build out experience and data sets with the activity of TORi there.

Denny Lanphier, CEO, Coherus Biosciences: The other point that I would make to dovetail on Doctor. Leibali’s remarks, Michael, is that when we brought Torpolimab in, we were very cognizant that it was differentiated, that it was a that it was a next generation PD one. It had shown activity subsequently in clinical trials rather as not, particularly in low PD L one states. And actually is licensed for low PD L one in esophageal in The EU. So we we we find it very gratifying that potential partners choose to our Palabin as a next generation PD one with its unique binding site and its high affinity and its high activity over the sort of first generation me too products that are out there.

And we expect to see, of course, more of these transactions.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Great. Well, let’s talk a little bit about CHS one fourteen. As you noted, this is a CCR eight targeting antibody that is intended to deplete Tregs. You presented some compelling clinical data AACR just, I guess, a couple 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.

Theresa Lavalet, Chief Development Officer, Coherus Biosciences: Sure. As Denny mentioned in his opening remarks, CHS one one four is a selective inhibitor of CCR eight, which is a target that is preferentially expressed on tumor resident Treg cells. And while it’s been well characterized that these Treg cells suppress immune response in tumors, they’re also important for no normal homeostasis. So broad depletion of Treg cells can lead to autoimmunity. So CCR8 has been an exciting target to identify, to be able to preferentially target tumor resident Treg cells.

The target itself is a GPCR, so a protein that is notoriously challenging to identify antibodies with selectivity. Our molecule is the only one that we’ve characterized or we’ve seen reported that has exclusive binding to CCR8. So any pharmacology that we’re characterizing, we don’t have to worry about off target toxicity. That we observed in the phase one clinical study a well tolerated safety profile dose proportionate PK. And 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.

So we had between 52 and 90 seven percent depletion within the tumor biopsies. And with that came a high infiltration of CD8 T cells. So we’ve 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’re now present and available for activation with things like PD-one inhibitors or T cell engagers. And a limitation for developing cell therapy like CAR Ts and solid tumors has been getting them into the tumor.

So CHS-one hundred fourteen showing those biomarker changes really lends itself for combination. And that proof of principle in the study we showed when we did the first seven patients in combination with Toripalumab, these late line treatment head and neck cancer patients. So in a fourth line patient, we had a dramatic partial response. So very early in the clinical studies seeing that activity, we’ve very excited for looking forward. We’re actively enrolling now second line head and neck cancer patients, so immediately after PD-one progression, combination with Torapalumab and CHS-one hundred fourteen to overcome that PD-one resistance in a 40 patient cohort to look at activity and getting the recommended phase two dose with Project Optimus.

And we also have a study open in 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. So we’re actively looking at internally other tumor types to add to our protocols.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: 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 one one four performs relative to competitor molecules.

Theresa Lavalet, Chief Development Officer, Coherus Biosciences: Yes. So we have the required potency on the molecule. And as I said, one of the things that we noted early on is the challenge in getting a selective molecule. So in our lead identification screen, so 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-one hundred fourteen, 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. So I worry about gut toxicity with that molecule. And 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.

So I think that we’re seeing some of that bear out in the clinic where they’re they’re having limitations based on the safety profile.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Got it. That’s helpful context. I think folks in the investor community, myself included, sometimes struggle interpreting early stage oncology data from small datasets, especially when, you know, of necessity, there’s not a control arm at least yet, and especially when it’s a combination trial. So the CHS one one four plus torpolimab 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?

Theresa Lavalet, Chief Development Officer, Coherus Biosciences: It it’s it’s always the totality of the data. And I think the safety one, very importantly, you know, the whole thesis with CCR eight 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, you know, 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. Biopsy data, I also would say, is very exciting, seeing that large infiltration of CD8 T cells was not expected.

So I find that very exciting and really sets it up well for combination with other agents to turn on the immune system. And we know that targeted therapies often give you a very strong response, but it’s not 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-one and every other available therapy, a fourth line patient responding, is incredibly exciting. And we have the study design now to look for that activity.

As we’re going into the PD-one refractory setting, I think that showing that particularly when we have PD L1 low PD-one progressed tumors, that gives you a confidence that the PD-one would not contribute significantly to the activity or meaningfully. And as we get the activity in the next cohorts, we would go into randomized studies.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Got it. Well, let’s talk about casdozoketug. 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.

Theresa Lavalet, Chief Development Officer, Coherus Biosciences: Sure. It’s an antibody against the IL 27 cytokine, so an antagonistic antibody to inhibit the cytokine. It’s well understood in inflammatory diseases. There’s a number of approved antibody in the IL-twenty seven family showing that you can rebalance the immune system by inhibiting a cytokine. This is the 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. So cytokines are context dependent, And all of the preclinical studies have said that the lung and liver tissue is particularly important areas where IL-twenty seven has immune suppressive phenotype. So seeing monotherapy responses in lung cancer and this activity in liver cancer has us incredibly excited. And what Denny mentioned in his opening whereas in a phase two study, 30 patients, we saw numerically higher activity in combination with atezo and bev than atezobev alone. But I think what really stood out is while the overall response rate of thirty eight percent and the PFS of eight point one months is numerically higher than what’s been reported, the 17 CR rate, it really stands out.

So if you look across phase three studies in first line HCC, none of them approached ten percent CR rate. The highest reported that I’m aware of is eight percent. So to see a seventeen percent CR rate is really a standout activity and really speaks to the biology of IL 27 being important in dampening the immune response. So inhibiting it allows for that stronger activity. We have a randomized study with ToriBev, casdozo versus ToriBev ongoing now.

So that randomized data will show that addition of casdozo and what that activity brings that’s enrolling this year. And we’re also looking to progress with a cooperative group the activity of casdozo and squamous lung.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Got it. So the development path from here for casdozo, when might we see those liver data? Is that a 2026 event or or later? And what’s the next step for the lung cancer trials?

Theresa Lavalet, Chief Development Officer, Coherus Biosciences: So we anticipate enrolling the HCC study this year, so data next year. And then for the lung cancer study, we’ve had interest from a cooperative group based on the strong clinical activity we’ve seen to date. And so it’s in the planning stages. So I think the formal announcement of that study opening and progressing would be the next milestone.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Okay. And, Denny, if I can editorialize a bit, it seemed as though you were emphasizing the liver cancer indication for casdozo in your opening remarks. Should that be the focus in our minds for casdozo, or was that just because those data are fresher off the press?

Denny Lanphier, CEO, Coherus Biosciences: I I think getting five complete responses, it is such a a startingly positive, result. It’s it’s hard not to really look at that as as one of the profound accomplishments in the last twelve months with respect to the pipeline. We look forward to the the the ToriBev data with it, but, I I think we’re we’re just very, I wouldn’t say confident, but we’re very hopeful that the patient benefit will read will continue, to read out. I think the as Teresa indicated, I think the lung would take a little longer. It’d be a larger study in the hands of the cooperative, but, ultimately, we’ll see how that goes.

But, certainly, the liver is doing, the liver with casdosa is doing very well here, early on, and very consistent with its MOA.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Okay. Great. Well, a lot to look forward to in the next twelve months then. Denny, in our final minute, I know if you have any closing remarks or if there’s anything in your pipeline that we failed to talk about you’d like to highlight.

Denny Lanphier, CEO, Coherus Biosciences: No. I think we covered the pipeline. I guess the the closing remark that I would say is that, the company established a very strong track record, previously with respect to development, you know, regulatory affairs, and commercial. We are we 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, like, Torazy and MPC, and beyond.

And 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 the fruition and then bringing the results forward. So all very positive for us as we as we focus on the execution. That’s what you’ll see from us.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Great. Well, we look forward to it. Thanks so much to Denny and Theresa and the Coherest team for your time and for everyone on the line.

Denny Lanphier, CEO, Coherus Biosciences: Thank you. See you around, Michael. Bye bye.

Mike Nadelkovich, Part of the large cap pharma research team, TD Cowen: Bye bye.

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