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BASKING RIDGE, N.J. - Lisata Therapeutics, Inc. (NASDAQ:LSTA), a clinical-stage biotech company with a market capitalization of $23 million, in collaboration with WARPNINE Incorporated, has announced preliminary positive outcomes from their Phase 1b/2a iLSTA trial, assessing the investigational drug certepetide in combination with standard-of-care chemotherapy and immunotherapy for the treatment of advanced pancreatic cancer. Despite a recent 26% decline in share price over the past week, InvestingPro analysis suggests the stock is currently undervalued. The findings will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium.
The trial, conducted at St John of God Subiaco Hospital in Western Australia, involves patients with locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC). The study divided participants into three cohorts to compare the effects of certepetide with standard chemotherapy and immunotherapy against standard care alone.
Interim analysis of the first 17 patients showed that after two treatment cycles, five patients experienced a partial response, with the remaining presenting stable disease. Following four cycles, nine patients demonstrated partial response, and one patient achieved a complete response. Notably, a significant decrease in CA19-9 levels, a marker for pancreatic cancer, was observed, and biopsies indicated increased tumor infiltrating lymphocytes, suggesting enhanced immune response.
Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical (TASE:PMCN) Officer at Lisata, emphasized the potential of certepetide to improve treatment outcomes for this patient group, which has historically shown limited response to immunotherapy.
Certepetide, designed to activate a novel uptake pathway for targeting and penetrating solid tumors, has garnered Fast Track and Orphan Drug Designations in the U.S. and E.U. for pancreatic cancer, as well as for glioma and osteosarcoma in the U.S.
Lisata Therapeutics focuses on developing therapies for advanced solid tumors and other serious diseases. Its CendR Platform® technology underpins commercial and R&D partnerships, with the company's projected capital expected to fund operations into early 2026.
WARPNINE, a not-for-profit clinical research organization, emphasizes the significance of collaborative efforts in advancing treatment possibilities for aggressive malignancies.
This report is based on a press release statement. The information provided is subject to further analysis and peer review, and the outcomes from this early-stage trial may not necessarily predict final results.
In other recent news, Lisata Therapeutics has been a subject of significant developments. First Berlin Research initiated coverage on Lisata Therapeutics with a Buy rating, acknowledging the company's innovative therapies for serious diseases. The firm's lead drug candidate, certepetide, is currently under clinical development across seven trials for various indications. Furthermore, Lisata has secured a significant licensing agreement with Qilu Pharmaceuticals for the exclusive rights to certepetide in Greater China, potentially leading to milestone payments totaling up to $221 million.
Recent developments also include a major exclusive license and collaboration agreement with Kuva Labs. The agreement grants Kuva Labs a worldwide exclusive license to develop and commercialize certepetide. In return, Kuva Labs will pay Lisata a 5% royalty on net sales of licensed products, among other financial commitments.
In terms of financial performance, Lisata reported a decrease in operating expenses to $5.3 million and an improvement in net losses at $4.9 million in its Q3 2024 earnings call. R&D expenses also fell by 24.8% to approximately $2.5 million. The company maintains a cash reserve of $35.9 million, which is expected to fund operations into early 2026. These are among the recent developments that have shaped Lisata Therapeutics' trajectory.
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