Coherus Oncology, Inc. Common Stock Study result

Good afternoon and welcome to Coherus Oncology's Tagmokitug interim clinical data disclosure conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus, Dr. Raj Diaz, Chief Medical Officer, and Dr. Theresa LaVallee, Chief Scientific and Development 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 for more information on risks and uncertainties. I'd like to turn the call over to Denny Lanfear.

Thank you, Carrie. Today, I'll be speaking to you about a few things. We'll first talk about the Tagmokitug opportunity in esophageal cancer, and then we will give you a data update on some additional indications. This will be followed by a KOL discussion and then some closing remarks and the Q&A. Joining me today is Dr. Raj Diaz, the company's Chief Medical Officer, as well as Dr. Theresa LaVallee, the company's Chief Scientific and Development Officer. Later on, we'll be joined by Dr. Doug Adkins from Wash U, our head and neck specialist, and Dr. Dan Feng from the Icahn School of Medicine at Mount Sinai, who will comment on the GI data. Let me talk a little bit about the pipeline and just make one brief statement. I direct you to the bottom of this slide, where we talk about our casdozokitug program, which we shall not discuss today.

I will, however, indicate to you that casdozokitug is showing clear dose-dependent activity, both with respect to response and duration. We expect to have a data disclosure for casdozokitug in January of 2027. Our fight against cancer focuses on overcoming immune resistance because it is there that the battle for extending patient survival is fought and either won or lost. Appropriately, patient survival is generally the approval endpoint for regulators. While our therapeutic focus includes the shorter-term reduction in tumor size or ORR, as it is important, we pursue clinical benefit, duration of response, and stable disease, where we seek to provide patients more life. This is our commitment to cancer patients to extend their lives. You can see this clearly here. LOQTORZI nearly doubling the 6-year survival of nasopharyngeal cancer patients on a background of chemotherapy versus chemotherapy alone.

This is a textbook example of extending survival by addressing immune resistance, in this case, with checkpoint therapy. Today, we report on our efforts to overcome a core part of cancer immune resistance and how the immune response mediation activity of T-reg cells in the mucosal system, extending top to bottom from head and neck through the GI tract, is hijacked by cancer. We have investigated several cancers along various lines of therapy, including first-line esophageal, second-line esophageal, second-line gastric and GI, second-line head and neck, and fourth-line plus colorectal, which I would comment is a particularly challenging setting. Tagmokitug has demonstrated clinical activity across all of these. As you will see today, these multiple solid tumor types with over 120 patients treated. I summarize our findings to date here for you as well as our projected development direction in first-line and second-line esophageal cancer.

First, across these studies, we saw a durable response and disease stabilization in pretreated IO-resistant populations, thereby demonstrating the ability to reverse immune exhaustion and rescue T-cells. With these studies, we saw broad pan-tumor activity of tagmokitug, including in head and neck cancer with enrichment for HPV-positive disease and in GI cancers, demonstrating clear dose-related activity. Very importantly, we saw no new safety signals beyond what is seen with PD-1 inhibitors and very manageable safety profile. The esophageal studies have shown particular promise with the confirmed overall response rate of 75% in all comers. That is inclusive of PD-L1 high and low and 100% in PD-L1 positive patients with an N equals 8 evaluable patients in first-line esophageal. Dr. Dias will address this momentarily. The clinical benefit in first-line and second-line esophageal patients with PD-L1 negative tumors was also of note.

As I indicated, we now will proceed with an integrated development plan forward in both first and second-line, which Dr. LaVallee will further talk about. We plan to expand cohorts to add more patients and add more longer follow-up, and this year, leverage FDA designations as we discuss with them the path forward and these additional cohorts and patients. With that, I'll hand the call over to Dr. Dias to discuss the specific results in first-line esophageal for you.

Raj? Thank you, Denny, and good afternoon, everyone.

Today, I'll present data from our TREGCHECK program. As a reminder, this is an ongoing program with continuing data entry. What I'll be presenting will be the interim data from the program. We'll present data from our GI program in four tumor settings, starting with esophageal squamous cell carcinoma in both first-line with chemotherapy and in second line. Our esophageal squamous cell cohorts will be the main focus in our development presentation due to the strong activity we're seeing. I'll also cover upper GI adenocarcinomas and colorectal carcinoma, as well as data in the PD-1 refractory head and neck squamous cell carcinoma cohort. As I go through the various cohorts, I'll cover key efficacy metrics and safety data.

For efficacy, as you heard from Denny Lanfear, the important metrics focus will not only be objective response rate as well as clinical benefit rate as well, a metric that includes CR plus PR plus stable disease greater than six months. CBR is an important measure of durability in early-stage trials, which is particularly important as the benefit of IO has been in extending the tail of the curve and improving survival, which, of course, is the approvable endpoint. Let me now start first with first-line esophageal squamous cell carcinoma. This was designed as a single-arm safety cohort with 12 treatment-naive patients with advanced metastatic disease, including patients that includes both PD-L1 positive and negative tumors. Enrollment is ongoing, and at the data cutoff date, 10 patients have been dosed and eight patients are evaluable.

We investigated our planned go-forward dose of 300 milligrams of tagmokitug in combination with toripalimab and with the U.S. standard of care chemotherapy, that is 5-FU and cisplatin, with safety as a primary endpoint and additional efficacy secondary endpoint. In terms of regional accrual, this was a multi-regional cohort with 20% of patients from the U.S., with 80% from the Asia-Pacific region. This slide outlines the interim clinical activity from the evaluable population in a waterfall plot. While the data set needs expanding, as you can see, tumor shrinkage was observed in 100% of evaluable patients.

As you can see from the legend below the waterfall plot showing PD-L1 status, the tumor shrinkage, importantly, was observed irrespective of PD-L1 status, so not only for PD-L1 positive patients, but also in patients who are PD-L1 negative, which, as you know, is not within the current approval in the U.S. label for PD-1s. In terms of best overall response of the eight evaluable patients, one patient had a confirmed complete response, and additionally, five patients had a confirmed partial response, of whom two patients continue on treatment as marked by the vertical arrows, overall representing a 75% confirmed overall response rate. For the two remaining evaluable patients on the far left of the waterfall, one had an unconfirmed PR. So meaning at the time of data cutoff, they had just received a single scan and are waiting for the next scan to see if this confirms.

The other patient had tumor shrinkage, not quite meeting the criteria for a confirmed PR, but showing durability beyond six months and continues on treatment. These two patients were PD-L1 negative, and again, they do not qualify at the moment for IO treatment in the U.S. For the PD-L1 positive patients, all responded with either a confirmed PR or CR, representing a 100% ORR in this population. Since our data cutoff date of October 14th, there has been some further improvement in activity with no attrition. We have since verified two additional participant scans that reflect the following. Firstly, the second from left patient with a PD-L1 negative unconfirmed PR has since confirmed. Secondly, a new evaluable patient who is not therefore currently represented on this waterfall has confirmed a PR.

If we were to include these additional scans since the October 14th date, the ORR in the evaluable population would go from 75% to 89%, and an ORR in PD-L1 positive patients would be maintained at 100%. For context, and bearing in mind that cross-trial comparisons do have limitations, the current standard of care of a PD-1 with chemo in the first-line setting have shown between a 44% and 59% ORR in PD-L1 positive patients. We do remain very encouraged by the interim activity demonstrated here. As we stress, durability and long-term stable disease is very important, and we look forward to these data continuing to mature. While these compelling data need to mature for durability, this does warrant cohort expansion to a larger data set, up to 30 or 40 patients.