Lisata Therapeutics
An American clinical-stage biopharmaceutical company developing cancer therapies and drug-delivery technologies.
Last updated August 24, 2026
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Overview
Lisata Therapeutics is an American clinical-stage pharmaceutical company focused on oncology. Its development strategy centers on certepetide, a tumor-targeting investigational agent also known as iRGD and CEND-1. Rather than functioning solely as a conventional cytotoxic medicine, certepetide is being developed as a therapeutic delivery enhancer intended to improve the penetration and distribution of anticancer treatments within solid tumors. The company’s stated area of activity includes the development and potential commercialization of new cancer therapies, with particular emphasis on combining certepetide with existing or emerging treatment modalities. Lisata was formed in September 2022 through the merger of Cend Therapeutics and Caladrius Biosciences. The transaction brought together Cend’s certepetide-centered oncology program and Caladrius’s publicly traded biotechnology platform, creating the company that operates under the Lisata Therapeutics name. The merger is a defining event in the company’s corporate history and explains why earlier references to the program may appear under the Cend Therapeutics name rather than Lisata. Certepetide has received regulatory designations from the United States Food and Drug Administration in pancreatic cancer. The FDA granted the product orphan-drug designation in 2019 and Fast Track designation in 2022. These designations recognize the investigational program’s potential relevance to a serious disease area and may facilitate aspects of clinical development and regulatory interaction, but they do not constitute approval or establish that the treatment is safe or effective. Lisata remains a clinical-stage company, meaning its principal product candidate is being evaluated through clinical development rather than marketed as an approved commercial medicine. Nonclinical research conducted by Lisata and other researchers has indicated that certepetide may increase the delivery of different categories of anticancer treatments into tumors. The reported scope of this research includes chemotherapy, immunotherapy, and RNA-based therapeutics. This platform-oriented approach positions Lisata around the problem of drug access within the tumor microenvironment: the company seeks to make existing or future treatments more effective by helping them reach relevant tumor tissue. The clinical value of that approach depends on results from human studies and on the performance of particular combination regimens. Lisata’s business scope is therefore concentrated in oncology research, clinical development, regulatory advancement, and the potential partnering or commercialization of cancer-treatment technologies. Publicly available reference material identifies certepetide as its principal named program but does not provide enough information to establish a complete commercial product portfolio, current revenue profile, headquarters location, executive roster, or operating presence outside the United States. On the available evidence, Lisata should be characterized as an active, U.S.-based clinical-stage oncology biotechnology company rather than a mature pharmaceutical manufacturer with marketed products.
History
Lisata Therapeutics emerged from the combination of Cend Therapeutics and Caladrius Biosciences in September 2022. The merger established a new oncology-focused company whose central development program is certepetide, also identified in public materials as iRGD and CEND-1. The corporate formation was significant because it transferred the development narrative of certepetide from Cend Therapeutics into a broader publicly oriented biotechnology organization operating as Lisata Therapeutics. Before the merger, the certepetide program had already received regulatory recognition in the United States. In 2019, the FDA granted the product orphan-drug designation for pancreatic cancer. This designation is intended for medicines being developed for rare diseases or conditions and can provide certain development and regulatory benefits; it is not marketing approval. In 2022, the FDA also granted Fast Track designation for certepetide in pancreatic cancer. Fast Track status is designed to support the development and review of therapies addressing serious conditions where unmet medical needs may exist, while likewise not establishing clinical efficacy or commercial approval. Lisata’s scientific and business rationale is based on using certepetide to improve the delivery of anticancer treatments into tumors. Nonclinical work reported by the company and other researchers has described enhanced delivery of multiple treatment classes when used with certepetide. These classes include conventional chemotherapies, immunotherapies, and RNA-based therapeutics. The approach is intended to address barriers that can limit the concentration or distribution of medicines within solid tumors. In this sense, certepetide is positioned as a potential combination-enabling technology as well as an investigational therapeutic product. Following its formation, Lisata has been described as a clinical-stage pharmaceutical company active in oncology and focused on developing and potentially commercializing cancer therapies. The available reference material does not establish that certepetide has received marketing approval or that Lisata has a marketed product portfolio. It also does not provide sufficiently detailed information about clinical outcomes, commercial revenue, headquarters, current executives, or international operations. Accordingly, the company’s documented history is best understood as the early corporate and regulatory history of an oncology-development business rather than the history of an established commercial drug manufacturer.
- 2022
Lisata Therapeutics is created through a merger
[1]Cend Therapeutics and Caladrius Biosciences merged in September 2022, forming Lisata Therapeutics.
- 2022
Certepetide receives FDA Fast Track designation
[1]The FDA granted Fast Track status to certepetide for pancreatic cancer development.
- 2019
Certepetide receives FDA orphan-drug designation
[1]The FDA granted certepetide orphan-drug designation for development in pancreatic cancer.
Products and positioning
A clinical-stage oncology biotechnology company developing certepetide as a platform for improving the delivery of anticancer therapies to solid tumors.
Investigational oncology therapeutic and tumor-targeting delivery enhancer
Certepetide
Certepetide, also known as iRGD and CEND-1, is Lisata’s named investigational oncology program. It is being developed to enhance the delivery of anticancer therapies into tumor tissue, particularly in solid-tumor settings. Nonclinical research has reported improved delivery of chemotherapy, immunotherapy, and RNA-based therapeutics when used with certepetide. The product received FDA orphan-drug designation for pancreatic cancer in 2019 and Fast Track designation in 2022. The available reference material does not indicate that certepetide has received marketing approval.
Brand decisions
2022
Combination of Cend Therapeutics and Caladrius BiosciencesM&ABackground
The transaction combined Cend Therapeutics’ certepetide-centered oncology program with Caladrius Biosciences to create a new oncology-focused company.
Action taken
The companies merged in September 2022 and began operating under the Lisata Therapeutics name.
Aftermath
Lisata became the corporate home for the certepetide development program and continued its clinical-stage focus in oncology.
Recent events
Caladrius Biosciences appoints Michael H. Davidson to its board[2]
Reported:
Caladrius Biosciences announced the appointment of Michael H. Davidson, MD, to its Board of Directors.
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