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8/7/2025
Good afternoon, everyone. Thank you for standing by. Welcome to the Cytomics Therapeutics Second Quarter 2025 Financial Results Call. Please be advised that today's call is being recorded. I would now like to hand the conference over to your host for today, Chris Arjun, Cytomics Chief Financial Officer. Please go ahead.
Thank you. Good afternoon, and thank you for joining us. Before we begin, I'd like to remind everyone that during this call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they're subject to inherent uncertainties and risks that are difficult to predict, and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. We undertake no obligation to update any forward-looking statements, whether as a result of new information future developments or otherwise. Earlier this afternoon, we issued a press release that includes a summary of our second quarter 2025 financial results and highlights recent progress at Cytomics. We encourage everyone to read today's press release and the associated materials which have been filed with the SEC. Additionally, the press release recording of this call and our SEC filings can be found under the Investors and News section of our website. With me on the call today is Dr. Sean McCarthy, Cytomics's Chief Executive Officer and Chairman. Sean will provide an update on our pipeline and company progress before I cover the financials for the quarter. We'll then conclude with a Q&A session. With that, I'll now turn the call over to Sean.
Thanks, Chris, and good afternoon, everyone. We're thrilled to be here today to review our progress for the second quarter, highlighted by the exciting clinical data we announced in May for CX2051, our ProBody antibody drug conjugate targeting EPCAM, which we view as having significant potential in colorectal cancer and potentially many other tumor types. We're also making great progress with our second current clinical program, CX801, that I'll come to a little later. I'll focus initially today on CX2051 and I'll work in colorectal cancer, which I'll refer to from here on as CRC. CRC remains one of the biggest unmet needs in oncology, with approximately 1.9 million patients diagnosed per year on a global basis. This disease burden is expected to increase considerably over the next couple of decades to more than 3 million and is currently the second leading cause of death by cancer worldwide. Despite many advances across many other cancer types in recent years, CRC has seen little impact from innovation over this period of time, resulting in current five-year survival rates in metastatic CRC of about 13%. New treatments like antibody drug conjugates are urgently needed to treat this cancer. In other solid tumor types, ADCs such as -HERS-U, Tredelvi, and Elahir have made a big difference for patients, but ADCs have yet to break through in CRC, representing a major scientific, clinical, and commercial opportunity. At CyTOMICS, we have intentionally designed CX2051 to address this opportunity, building on years of experience in how to optimally leverage our pro-body technology for the maximum benefit of cancer patients. Let me recap the key design elements of CX2051. EtCAM is a very highly expressed target in CRC, making it very attractive for an ADC. The payload on CX2051 is a topoisomerase-1 inhibitor, which is ideally matched to CRC, where the topo-1 inhibitor, arinitican, has been a core component of the standard of care for many years. And thirdly, critically, CX2051 uses CyTOMICS pro-body masking technology to limit binding in normal tissues, something that has thwarted previous attempts to drug epcAM. Our initial experience with CX2051 in the clinic, announced in May, is very encouraging. We have focused our phase one clinical evaluation exclusively in CRC, with the goal of delivering clear clinical proof of concept in this high area of unmet need. I'd like to briefly recap the CX2051 initial phase one data from May. For context, CX2051 has initially been studied in a fifth-line CRC patient population, where approved standard of care therapies are typically associated with 1% to 2% response rates and progression pre-survival of only two to three months. In comparison to these benchmarks, CX2051 has demonstrated robust clinical activity, with a 28% confirmed overall response rate, 94% disease control, and 5.8 months of preliminary progression pre-survival in the first 18 efficacy of animal patients at relevant dose levels. We're also encouraged to have observed clinical activity, including confirmed objective responses across a relatively wide range of doses. Our initial data has also validated that epcAM expression is abundant in late-line CRC, with every invaluable patient having high target levels. This is important because it suggests that CX2051 may broadly address CRC and may not require patient selection, potentially a significant commercial advantage. Furthermore, our CX2051 masking strategy has succeeded in avoiding classic epcAM toxicities, such as pancreatitis, that have impeded the successful development of drugs against this target previously. In terms of next steps, we have initiated dose expansions at doses of 7.2, 8.6, and 10 milligrams per kilogram, administered every three weeks, and we are targeting enrollment of approximately 20 patients at each dose level. Enrollment is going well, and we remain on track for an updated data set from a total of about 70 patients in Q1, 2026. Our goals for the dose expansions are to more fully characterize the dose response of CX2051, both in terms of clinical activity and safety, with a goal to inform dose selection for phase two. In terms of safety, the most common adverse events in the interim phase one data were diarrhea, nausea, vomiting, and anemia. In the expansion phase, we're paying particular attention to management of diarrhea using prophylactic medications, and we'll continue to iterate and refine our AE management strategies to best position CX2051 for phase two and beyond. In parallel to enrolling the expansion cohorts, we are in the process of developing our phase two strategy in Late Line CRC, and planning for potential initiation during the first half of 2026. While these are next steps will of course be data dependent, our current view is that the next study would likely evaluate CX2051 monotherapy in fourth line CRC, based on the high MET need, the potential speed to market, and the multi-billion dollar market opportunity we see in this treatment setting. Looking ahead to the longer term, CX2051 is also anticipated to have potential in earlier lines of CRC therapy, and ultimately may be positioned, we believe, to replace arinatican as a foundational component of CRC treatment. In support of this strategy, we anticipate starting combination studies in CRC in 2026. Now turning to CX801, our masked interferon alpha 2b program that we're developing in combination with the PD1 inhibitor, Keytruda. Interferon alpha is a powerful immune system modulator with known anti-cancer activity across multiple tumor types, including renal cancer, bladder cancer, and melanoma. But it's fallen out of clinical use in oncology due to its poor tolerability. We designed CX801 to really clamp down on the undesired broad systemic activity of interferon and localized activity to the tumor microenvironment. In May of 2025, during Q2, we dosed the first patient in the combination arm of our phase one study with Keytruda. This study is focused in metastatic melanoma and we're targeting initial data for the combination in 2026. In the fourth quarter of this year, we anticipate providing a first look at translational data for monotherapy CX801 in paired tumor biases and specifically how it's modulating the tumor microenvironment, including potential upregulation of interferon-stimulated genes like PDL1. Positive early results here would provide evidence that the mechanism of action is working as designed, underpinning our rationale for the Keytruda combination and supporting our vision of turning cold tumors hot with this novel immunotherapy. We look forward to providing this initial CX801 translational update in Q4 this year. With that, let me turn the call over to Chris for updates on our finances.
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