If You Invested in Lisata Therapeutics Inc (LSTA)

Lisata Therapeutics, Inc. (Nasdaq: LSTA) is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of therapies for advanced solid tumors and other serious diseases. The company is centered around certepetide (formerly LSTA1), an investigational internalizing RGD (iRGD) cyclic peptide designed to activate a novel uptake pathway so that co-administered or tethered anti-cancer drugs can selectively target and penetrate solid tumors more effectively.

According to the company’s public disclosures, certepetide actuates a tumor-specific active transport system that enables systemically administered anti-cancer agents to penetrate and accumulate in tumors with greater efficiency. In addition to its drug delivery effects, certepetide has been shown to modify the tumor microenvironment, diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration and making tumors more susceptible to immunotherapies. Lisata and its collaborators report non-clinical and clinical data indicating enhanced efficacy and acceptable safety when certepetide is combined with existing and emerging therapies, including chemotherapies, immunotherapies, RNA-based therapeutics and antibody-drug conjugates (ADCs) in solid tumor models.

Core development focus: certepetide in solid tumors

Lisata states that it operates with a single primary development program built around certepetide. The company’s disclosures describe multiple ongoing or planned clinical studies in which certepetide is combined with standard-of-care (“SoC”) regimens across several solid tumor indications. These include metastatic pancreatic ductal adenocarcinoma (mPDAC), locally advanced non-resectable pancreatic ductal adenocarcinoma, cholangiocarcinoma, glioblastoma multiforme (GBM), and selected colon and appendiceal cancers.

Key certepetide-related programs described by Lisata include:

• ASCEND: A Phase 2b double-blind, randomized, placebo-controlled trial in mPDAC, evaluating two dosing regimens of intravenous certepetide in combination with SoC chemotherapy (gemcitabine and nab-paclitaxel) versus SoC alone. The study is conducted across sites in Australia and New Zealand. Preliminary data from both dosing cohorts, as reported at oncology conferences, have shown positive trends in survival and response measures, with no increase in adverse events beyond those seen with SoC alone.
• BOLSTER: A Phase 2a double-blind, placebo-controlled, multi-center randomized trial in the U.S. evaluating certepetide with SoC chemotherapy in first- and second-line cholangiocarcinoma. Lisata has reported completion of enrollment in first-line cholangiocarcinoma ahead of plan and the addition of a second-line cohort, with the goal of improving outcomes in patients who have progressed after first-line treatment.
• CENDIFOX: An investigator-initiated Phase 1b/2a open-label trial in the U.S. at The University of Kansas Cancer Center, evaluating certepetide in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colon and appendiceal cancers. Lisata reports that the trial is designed to generate pre- and post-treatment tumor tissue for immune profiling and long-term outcome data. Preliminary pancreatic ductal adenocarcinoma cohort results presented at a pancreatic cancer research conference indicated that combining certepetide with FOLFIRINOX was safe and feasible, with reported R0 resection and pathologic response rates, and evidence of tumors shifting from “immune-cold” to “immune-hot.”
• iLSTA: A Phase 1b/2a randomized, single-blind, single-center safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., evaluating certepetide plus SoC chemotherapy (nab-paclitaxel and gemcitabine) and SoC immunotherapy (durvalumab) versus SoC alone in locally advanced non-resectable PDAC. Lisata and WARPNINE have announced completion of enrollment and preliminary data showing overall response and disease control rates that support the potential for certepetide to enhance immunotherapy effectiveness.
• GBM study: A Lisata-funded Phase 2a double-blind, placebo-controlled, randomized proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus SoC alone in newly diagnosed glioblastoma multiforme. The study is being conducted across sites in Estonia and Latvia, with plans to include an additional site in Lithuania.
• Greater China license with Qilu Pharmaceutical: Qilu Pharmaceutical, as licensee of certepetide in the Greater China territory, is conducting a Phase 2 trial of certepetide plus gemcitabine and nab-paclitaxel as first-line treatment for mPDAC. Preliminary data shared at an oncology meeting were reported to corroborate earlier Australian trial findings, and Qilu has completed enrollment in its Phase 2 study.

Regulatory designations and technology platform

Lisata reports that certepetide has received multiple regulatory designations. These include Fast Track designation in the U.S. and Orphan Drug Designation for pancreatic cancer in both the U.S. and European Union. In the U.S., certepetide also holds Orphan Drug Designation for glioma, osteosarcoma and cholangiocarcinoma, as well as Rare Pediatric Disease Designation for osteosarcoma. These designations reflect regulatory recognition of the serious nature of the targeted diseases and the potential for certepetide-based approaches.

The company describes certepetide as the core of its CendR Platform® technology, which underpins both its internal clinical programs and external collaborations. Lisata states that it has established commercial and research and development partnerships that apply certepetide’s biology across different therapeutic modalities, including ADCs and AI-enabled drug discovery efforts.

Partnerships and collaborations

Lisata’s public communications highlight several notable collaborations:

• Catalent, Inc.: Lisata has entered into a worldwide non-exclusive license agreement granting Catalent rights to use certepetide and its analogs as SMARTag® ADC payloads across multiple ADC programs designed for difficult-to-treat diseases. Under this agreement, Catalent assumes responsibility for research, development and commercialization costs. Lisata is eligible for development milestone payments and tiered revenue sharing on future sales and partnerships, as well as a share of certain sublicense consideration. Preclinical data presented by Catalent have shown that incorporating certepetide as a non-cytotoxic ADC payload can improve ADC efficacy and broaden the distribution of cytotoxic payloads within the tumor microenvironment.
• GATC Health: Lisata has formed a strategic alliance with GATC Health to use GATC’s AI-powered Multiomics Advanced Technology™ platform. The collaboration is intended to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications and identifying combination regimens.
• WARPNINE Incorporated: In Australia, Lisata collaborates with WARPNINE, a not-for-profit clinical research organization, on the iLSTA trial in locally advanced non-resectable PDAC. Lisata provides drug supply and clinical strategy, while WARPNINE contributes funding support and operational execution at St John of God Subiaco Hospital.
• Academic and regional partners: The ASCEND trial is led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. The CENDIFOX trial is conducted at The University of Kansas Cancer Center. The GBM study involves sites in Estonia and Latvia, with plans for an additional Lithuanian site. These collaborations provide access to specialized oncology centers and patient populations.

Intellectual property and corporate profile

Lisata has disclosed that the United States Patent and Trademark Office has issued a composition of matter patent for certepetide (U.S. Patent No. 12,351,653), covering its chemical structure, pharmacokinetic properties, manufacturing methods and applications in treating solid tumors. The patent extends certepetide’s protection into the next decade, with potential for further extensions, and grants Lisata exclusive rights to the drug substance.

The company is headquartered in Basking Ridge, New Jersey, and trades on the Nasdaq Capital Market under the symbol LSTA. Public filings and press releases indicate that Lisata is a clinical-stage entity with one primary operating segment focused on research and development of its investigational drug product. The company has reported maintaining a cash runway that it believes will fund operations into future periods, supporting ongoing clinical trials and partnership activities.

Role within oncology and drug development

Within the broader oncology landscape, Lisata positions certepetide as a potential enabling technology for multiple treatment modalities in solid tumors. By focusing on tumor-specific uptake pathways and modulation of the tumor microenvironment, the company aims to improve the performance of standard chemotherapies, immunotherapies, RNA-based therapeutics and ADCs in indications such as pancreatic cancer, cholangiocarcinoma and glioblastoma. Its collaborations with contract development and manufacturing organizations, AI-driven discovery platforms, non-profit research organizations and academic cancer centers reflect a model that combines internal development with external expertise.

Frequently asked questions about Lisata Therapeutics (LSTA)

The following FAQs summarize key points drawn from Lisata’s public disclosures and regulatory filings.