Lisata Therapeutics Inc (NASDAQ:LSTA) said on Thursday it expects a data-rich year ahead as it advances multiple trials of its lead asset, certepetide, a novel peptide-based therapy being tested in a range of solid tumors.
The New Jersey-based company said it remains focused on progressing certepetide through clinical and preclinical studies, with several important data readouts expected over the course of 2025 and into 2026, including results from the second cohort of its ASCEND trial in metastatic pancreatic cancer and preclinical work with Catalent’s antibody-drug conjugate (ADC) platform.
"Lisata maintains momentum into 2025 despite a challenging market for small-cap healthcare companies," CEO David Mazzo said in a statement, highlighting the company’s strengthened financial position and upcoming engagements with global regulators.
The ASCEND trial, a randomized, placebo-controlled Phase 2b study conducted in Australia and New Zealand, is evaluating certepetide alongside standard-of-care chemotherapy in first-line metastatic pancreatic cancer patients. Preliminary data from Cohort A showed a positive survival trend, including four complete responses. Cohort B data has been accepted for presentation at the ESMO GI Congress in July.
Pipeline progress
Another key program, the US-based BOLSTER trial in cholangiocarcinoma, is on track for a mid-year topline data readout. Lisata also recently halted enrollment in its second-line cohort to accelerate analysis and conserve capital.
Across its pipeline, the company is exploring certepetide’s potential to enhance the efficacy of chemotherapies, immunotherapies, and RNA-based treatments by improving drug penetration into tumors and modulating the tumor microenvironment. The peptide has earned multiple regulatory designations, including Fast Track and Orphan Drug status in the US and EU for several cancers.
Lisata is also preparing for final analyses from the CENDIFOX trial in pancreatic, colon, and appendiceal cancers, with data expected in the coming months. Meanwhile, international partners continue to advance development; Qilu Pharmaceutical in China is nearing completion of a Phase 2 trial, which could trigger a $10 million milestone payment if it progresses to Phase 3.
In parallel, Lisata is expanding preclinical collaborations. Recent agreements with Catalent and Kuva Labs will explore certepetide as a drug delivery enhancer in ADCs and as a targeting agent for cancer imaging, respectively. The company is also assessing potential uses in non-cancer indications such as endometriosis through work with the University of Cincinnati.
“Overall, our focus remains on evaluating certepetide in multiple clinical and preclinical studies across a variety of solid tumors and non-cancer indications,” Mazzo added.
Financial highlights
Lisata reported a net loss of $4.7 million for the first quarter of 2025, a slight improvement from the $5.4 million loss in the same quarter last year.
As of March 31, the company had about $25.8 million in cash, cash equivalents, and marketable securities.
The company reported a quarterly operating expense of $5.8 million, down 11% year over year, and now projects cash runway into the third quarter of 2026.