Coherus Oncology, Inc. Common Stock 2026 Q2 Earnings Call

Good afternoon, and welcome to Coherus Oncology's second quarter 2026 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus, Dr. Raj Diaz, Chief Medical Officer, Dr. Theresa LaVallee, Chief Scientific and Development Officer, Sameer Goregaoker, Chief Commercial Officer, and Bryan McMichael, Chief Financial Officer. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus' current expectations about future events. Actual results may vary significantly, and we undertake no duty to update or revise any forward-looking statements. Please see the press release that we issued today and our quarterly report on Form 10-Q for more information on risks and uncertainties. Now I'll turn the call over to Denny.

Thank you, Kari, and thank you all for joining us this afternoon on our Q2 2026 quarterly call. As you know, we are now in an exciting period of initial clinical data generation and readouts, not definitive data reporting. We'd like to provide you with the available insights on how things look so far. First, let me make a few remarks about the scientific focus on overcoming immune resistance in cancer to provide you with a lens through which to view our pipeline and our development strategy. A review of the data on immune oncology drugs in cancer reminds us that immunotherapy's benefit is primarily seen at the far end of the survival curve, where it matters most to both patients and regulators. Additionally, the combination agents can make a substantial difference.

A good example is the combination of chemotherapy and PD-1s, where PD-1s revolutionized cancer care by addressing immune invasion and showed some of the most pronounced survival benefits when used in combination with drugs that lead to tumor cell death. It's essential to keep in mind that tagmokitug, as a T-reg depleting agent, is mechanistically positioned not as another response rate agent like chemo or ADCs, but as a horizontally enabling durability layer that removes the brake, T-regs, which potentially limit both depth and the durability of response with various active agents. This translates directly to our tagmokitug development program, which first represents a rational scientific framework to evaluate T-reg depletion across a number of cancers and various lines of therapy for response and duration.

Secondly, it's deliberately constructed to provide insights as to where T-reg depletion is best positioned, with what combinations, and in what lines of therapy, to identify the best patients for long-term survival benefit, the key approval criteria. Importantly, to elucidate the relationship of T-reg depletion with immune context, T cells, and other factors necessary for efficacy. Understanding the relationship between biomarkers and immune context factors and response duration requires a robust biomarker program for context and to provide the direction for future development. We have this in place and are in the process of analyzing this data. Our immune resistance focus on survival and duration of clinical benefit also translates to the casdozokitug program and the ongoing first-line HCC study in combination with toripalimab and bevacizumab, which follows the previous casdozokitug study that demonstrated improved survival and strong complete response data.

Noting both the duration and the depth of response took several months. Again, we have the appropriate biomarker program in place and are in the process of analyzing this data now that CADILYZE study is fully enrolled. We previewed this for you on our last call. Today, on this call, Dr. LaVallee, our Chief Scientific and Development Officer, will go further and discuss with you TIRI, our tumor immune regulatory index, in the context of our tagmokitug studies. Theresa will be followed by our Chief Commercial Officer, Sameer Goregaoker, who will review the LOQTORZI business, and Bryan McMichael, our Chief Financial Officer, who will give you some color on our quarterly operational results and cash and balance sheet. First, let me hand things over to Dr. Diaz, our Chief Medical Officer, to provide you an update on the emerging data from the clinical studies.

Raj. Thank you, Denny. I'm pleased to report that three of our studies have completed full enrollment, and I'm able to provide some initial color on emerging data sets.

In addition to our casdozokitug study in first-line HCC already being fully enrolled, our Tagmo cohorts in both head and neck squamous cell and colorectal cancer are also now fully enrolled. However, other cohorts have yet to complete patient accrual. This is important to keep in mind since, as we approach initial data readouts for our clinical program, the two key determinants of data timing will be the numbers of patients in study and also the numbers of scans that may be required to provide a meaningful indication of activity. In addition to providing information of response, having a sufficient number of scans provides valuable information on durability of activity for both response and stable disease.

This is particularly important as much of the benefit with IO has been seen in extending the tail of the curve, i.e., the durability of activity. We have two active protocols and one to initiate in the coming few months. Let me take each pipeline program in turn, starting first with the TREGCHECK program for tagmokitug, our highly selective CCR8 cytolytic antibody. Our first protocol is looking at Tagmo in head and neck squamous cell carcinoma. This is a 40-patient study investigating two doses of Tagmo in combination with toripalimab in a second-line head and neck squamous cell population, asking the very specific question of whether we're able to reverse PD-1 resistance in a second-line population. As mentioned, I'm pleased to report that this is now fully enrolled.

This study builds upon the prior data we've previously communicated at AACR last year, where in earlier stages of this same study, we demonstrated clear tumor remodeling with Tagmo monotherapy and a partial response in a fourth-line patient with HPV-positive head and neck squamous cell out of seven patients who received the combination of Tagmo and Turi. The ongoing study is yet to have a sufficient number of patients reaching maturity of data that would trigger formal data cleaning, but I can make the following high-level comments based on emerging data from a subset of patients. Firstly, the combination of Tagmo and Turi has thus far shown an acceptable and manageable safety profile. Secondly, we've seen evidence that the addition of Tagmo to Turi for the treatment of PD-1 resistance in the second-line head and neck population has shown activity with respect to response rate and treatment duration.

In particular, in our analyses of baseline tumor samples, preliminary data from the early batches of samples indicates there may be an immune context that enriches for patient benefit. Based on the small sample size of the data we have in the subset of patients with matched biomarker data, we're seeing greater activity in patients who are HPV-positive, an area where there remains a significant unmet medical need, and in patients who have a higher tumor immune regulatory index or TIRI score, a point on which Theresa will elaborate on momentarily. With the important caveats that these initial observations are based on data that is not yet fully mature, and importantly, the data that has not yet been formally cleaned and may therefore be subject to change. If these trends persist with further maturation of data, this may support an immune strategy in head and neck squamous cell carcinoma.

I anticipate further maturation of the data over the coming months, including analysis of the remaining biomarker samples, and current projections indicate we're likely to have all patients having had sufficient follow-up and biomarker analyses to enable a formal disclosure in October. Moving on to our second protocol, which investigates Tagmo in a selection of GI cancers. Cohort A is a second-line upper GI adenocarcinoma population, including gastric adenocarcinoma, esophageal adenocarcinoma, and GEJ cancers with 40 patients, again, with two doses of Tagmo in combination with Turi. Whilst we are nearing completion of accrual, we have not yet done so, and therefore it's too early to make any more detailed comments on this cohort.

In terms of our projections, we anticipate that the full complement of patients will have had a sufficient number of scans in the coming months, and therefore, we currently anticipate the ability to report data later this year. Cohorts B and C are investigating the Tagmo Turi combination in second-line and first-line esophageal squamous cell carcinoma, respectively. Enrollment continues on both cohorts. The second-line cohort is looking at 20 patients with a doublet combination, and the first-line cohort adds in chemo as well to the doublet as a safety cohort of 12 patients. Thus far, we've seen an acceptable and manageable safety profile. Cohort D evaluates Tagmo in combination with Turi in colorectal carcinoma, with 20 patients in a fourth-line plus MSS population, with initial focus on non-liver mets and with an intention to expand to a potential additional 21 patients and also a liver mets population.

I'm very pleased to say that despite being the last cohort to start, we've completed accrual of the initial 20 patients, which really is a clear recognition of the unmet medical need in colorectal carcinoma. Current projections indicate that all 20 patients should have had a sufficient number of scans in the next couple of months. We continue to anticipate initial data to be available later this year. Finally, the third protocol, which is designed to accommodate tagmokitug combinations with novel agents, remains on track to initiate in the fall timeframe with its first cohort of tagmokitug in combination with pasritamig, J&J's T-cell-engaging in metastatic castrate-resistant prostate cancer. Let me end with casdozokitug in hepatocellular carcinoma. This is a 72-patient study investigating the casdozokitug TIRI bevacizumab combination in a first-line HCC population and is designed to achieve three things.