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REDWOOD CITY, Calif. - Coherus BioSciences, Inc. (NASDAQ: CHRS), a biotechnology company with current annual revenues of $267 million and a market capitalization of $121 million, today unveiled promising data from a Phase 1 clinical trial of CHS-114, a novel cancer therapy. According to InvestingPro data, the company maintains a healthy gross profit margin of 56% despite operating in the challenging biotech sector. The study, presented at the American Association for Cancer Research Annual Meeting, showed clinical efficacy of CHS-114 in combination with toripalimab for treating head and neck squamous cell carcinoma (HNSCC).
The trial demonstrated a confirmed partial response in a patient with HNSCC who had not responded to prior PD-1 inhibitor treatments. This response was coupled with a significant reduction in CCR8+ T regulatory (Treg) cells and an increase in CD8+ T cells, indicating anti-tumor activity and providing proof of the drug’s mechanism.
The safety profile of CHS-114, in combination with toripalimab, was consistent with expectations for advanced disease and the known safety profile of toripalimab, supporting its continued evaluation. The results have led to the expansion of the study, with a focus on HNSCC and gastric cancer, and the selection of two doses for further optimization.
CHS-114 is a selective cytolytic anti-CCR8 antibody, which targets CCR8+ Treg cells within the tumor microenvironment while preserving healthy T cells. According to Dr. Rosh Dias, Coherus’ Chief Medical Officer, these early clinical results are highly encouraging and support the potential of CHS-114 to treat a range of solid tumors.
Dr. Douglas Adkins from Washington University highlighted the importance of the treatment, which appears to effectively deplete Treg cells and remodel the tumor microenvironment without causing collateral autoimmune disease.
The ongoing Phase 1 trial will continue to assess CHS-114’s efficacy and safety, with results expected in the first half of 2026. This study aims to meet regulatory requirements under Project Optimus and establish a recommended phase 2 dose. InvestingPro analysis indicates the company is currently burning through cash, with negative free cash flow of $20.7 million in the last twelve months, highlighting the capital-intensive nature of drug development.
Coherus will discuss these findings in an investor and analyst call today, featuring insights from study investigator Dr. Adkins. The company’s broader strategy involves advancing the development of new indications for its next-generation PD-1 inhibitor, LOQTORZI®, and other pipeline candidates, targeting various cancers.
This news article is based on a press release statement from Coherus BioSciences, Inc.
In other recent news, Coherus BioSciences reported a strong fourth quarter for 2024, with revenue reaching $54.1 million, surpassing analyst expectations of $44.15 million. The company’s earnings per share (EPS) were slightly better than anticipated at -$0.28, compared to the forecasted -$0.30. Shareholders have approved the sale of Coherus’s UDENYCA franchise to Intas Pharmaceuticals, a significant move in the company’s strategic shift towards focusing on oncology. The proceeds from this divestiture will be used to repurchase $170 million in convertible notes, as announced by the company. Additionally, Coherus received an upgrade from H.C. Wainwright, which maintained a Buy rating for the stock, following the successful sales growth of its cancer treatment, Loqtorzi. Loqtorzi sales rose by 29% quarter over quarter, reaching $7.5 million in the fourth quarter. The company is also preparing for the departure of Chief Commercial Officer Paul Reider, effective April 30, 2025, as he pursues other opportunities. Coherus has committed to repurchasing the remaining convertible notes contingent on the completion of the UDENYCA sale, which is expected to close early in the second quarter of 2025.
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