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SOUTH SAN FRANCISCO - CytomX Therapeutics, Inc. (NASDAQ:CTMX) announced today the initiation of a Phase 1 clinical trial for its novel cancer treatment, CX-801, in combination with Merck’s KEYTRUDA® (pembrolizumab), marking a significant development in therapies for metastatic melanoma. This trial follows the successful completion of early dose escalation studies using CX-801 as a monotherapy. The company, currently valued at $320 million, has seen its stock surge over 127% in the past six months, according to InvestingPro data.
CX-801 is a conditionally activated biologic, specifically a dually masked interferon alpha-2b PROBODY® cytokine, designed to target the tumor microenvironment while minimizing systemic toxicities. This approach aims to leverage the immune-stimulating properties of Interferon alpha-2b in conjunction with checkpoint inhibition therapy provided by KEYTRUDA®, a widely recognized anti-PD-1 therapy. With a strong gross profit margin of 100% and healthy balance sheet showing more cash than debt, CytomX appears well-positioned to advance its clinical programs, though InvestingPro analysis indicates the company is rapidly burning through its cash reserves.
The decision to advance to combination trials came after the successful clearance of the first three CX-801 monotherapy dose escalation cohorts. Dr. Wayne Chu, M.D., Chief Medical Officer of CytomX Therapeutics, expressed optimism about the potential benefits of this combination therapy for patients with PD-1 refractory melanoma, a condition with a high need for effective treatments.
CytomX, a clinical-stage biopharmaceutical company, focuses on developing innovative biologics with its PROBODY® therapeutic platform to create safer and more effective cancer treatments. The company’s pipeline includes various therapeutic candidates such as antibody-drug conjugates (ADCs), T-cell engagers, and cytokines.
The trial’s commencement is a step forward for CytomX’s vision to establish conditionally activated treatments as the new standard in cancer care. The company anticipates initial Phase 1a translational and biomarker data from the trial in the second half of 2025.
Investors and industry watchers are advised that this information is based on a press release statement from CytomX Therapeutics, and the outcomes of clinical trials are subject to various risks and uncertainties. The forward-looking nature of clinical development means that the results from earlier stages may not be indicative of future outcomes. According to InvestingPro data, five analysts have recently revised their earnings expectations downward, though the company is still expected to remain profitable this year. For deeper insights into CytomX’s financial health and detailed analysis, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, CytomX Therapeutics reported its financial results for the first quarter of 2025, significantly surpassing earnings and revenue expectations. The company achieved an earnings per share of $0.27, which was notably higher than the forecasted $0.06, and generated revenue of $50.92 million, exceeding the anticipated $29.7 million. Additionally, CytomX secured $100 million in financing to support ongoing projects, highlighting its strategic financial positioning. In clinical developments, CytomX released promising data for its EpCAM ProBody Topo-1 ADC, CX-2051, in a study involving patients with advanced colorectal cancer. The data showed a confirmed response rate of 28% in unselected patients, with a higher response rate of 43% at the highest dose level. H.C. Wainwright upgraded CytomX’s stock to a buy, setting a price target of $5.00, driven by the impressive clinical data. The company plans to expand patient enrollment to further assess the potential of CX-2051, aiming to select the Phase 2 dose. These developments underscore CytomX’s advancements in its oncology pipeline and its focus on targeted cancer therapies.
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