Lisata Therapeutics Receives Paediatric Investigation Plan Waiver from the European Medicines Agency for Certepetide in Pancreatic Cancer

Waiver confirms that paediatric studies of certepetide in pancreatic cancer are not needed

Significant clinical trial burden and costs avoided due to waiver

BASKING RIDGE, N.J., May 20, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that it has reached agreement with the European Medicines Agency (the “EMA”) on a Paediatric Investigation Plan (“PIP”) for Lisata’s lead investigational product, certepetide (formerly LSTA1), in pancreatic cancer. The EMA has agreed to a product-specific full pediatric waiver for certepetide in pancreatic cancer.

The Paediatric Committee (“PDCO”) of the EMA recommended and the EMA granted a waiver for certepetide for all subsets of the pediatric population for the treatment of pancreatic cancer on the grounds that “pancreatic cancer occurs only in adults.” This waiver removes any requirement for Lisata to conduct clinical studies of certepetide in children in support of an overall marketing authorization application in Europe for pancreatic cancer. It also allows Lisata to focus its development efforts on bringing this therapy to relevant patients with pancreatic cancer as quickly as possible. By eliminating any requirement for pediatric clinical studies in pancreatic cancer, the waiver significantly reduces the clinical trial burden and overall cost of completing development and achieving market registration in Europe.

“We are pleased that the European Medicines Agency has confirmed that pediatric studies evaluating certepetide are not needed to support a market authorization application in pancreatic cancer,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “With a waiver in hand, we are now able to streamline our development program as we work toward certepetide’s product registration in Europe. This full waiver is specific to pancreatic cancer and will not affect our commitment to evaluate certepetide in other pediatric solid tumors as required.”