Lisata Therapeutics Inc (NASDAQ:LSTA) has ended its first quarter of 2024 with nearly $43.3 million in cash to fund its tumor-fighting drug development activities well into the coming year.
CEO David Mazzo told shareholders that the company is off to a strong start to 2024, with Phase 2b ASCEND trial top-line data expected in fourth quarter.
Those results, Mazzo said in a statement, could have “transformative” potential for the Basking Ridge, New Jersey-based company.
The company's focus on certepetide, an investigational drug designed to enhance the delivery of anti-cancer drugs to solid tumors, has shown promising results in preclinical and clinical trials across various tumor types. Notably, certepetide has received orphan drug and rare pediatric disease designations for osteosarcoma, further validating its therapeutic potential.
The results of the Phase 2b trial will be “instrumental” in determining the future of Lisata, Mazzo said, adding that the firm plans to use them to explore conditional approvals with various regulatory agencies or design a Phase 3 program in pancreatic ductal adenocarcinoma.
“Since the start of the year, we have received both US FDA Orphan Drug and Rare Pediatric Disease designations for certepetide, previously known as LSTA1, in osteosarcoma, further validating the broad therapeutic potential of this innovative therapy,” Mazzo said.
“We are energized by the progress we are making and excited about Lisata’s prospects.“
Lisata remains financially strong, with cash reserves projected to fund operations into early 2026, supporting ongoing and planned clinical trials.
During the first quarter of 2024, operating expenses decreased slightly compared to the previous year.
Research and development expenses remained stable at approximately $3.2 million for the first quarters of 2024 and 2023, with a slight increase attributed to enrollment activities for the BOLSTER trial, while general and administrative expenses decreased by $0.3 million or 8.3% due to various factors including staffing adjustments and reduced insurance premiums, resulting in a decrease in net losses from $6.2 million in Q1 2023 to $5.4 million in Q1 2024.
“Our continued prudent financial management allows us to reaffirm our projection that currently available cash will fund operations into early 2026, providing a solid foundation to fund all ongoing and planned trials through to completion,” Mazzo added.
“More than ever, we remain confident in our ability to execute our development activities with the goal of reaching critical milestones at the earliest possible juncture.”