Lisata Therapeutics Inc (NASDAQ:LSTA) reported significant advancements across its clinical portfolio in the third quarter, with multiple key data readouts projected over the next 18 months.
Lisata’s financial performance for the quarter showed a 10.5% year-over-year decrease in operating expenses, down to $5.3 million from $6 million. This was attributed to lower research and development costs associated with modifications to its trial protocols.
Research and development expenses fell to $2.5 million, driven by changes in the BOLSTER trial and a reduction in clinical organization expenses, as well as the absence of last year’s startup costs related to its glioblastoma multiforme study.
General and administrative expenses rose slightly to $2.8 million, attributed primarily to increased consulting costs.
Its net loss decreased to $4.9 million from $5.3 million a year earlier.
With approximately $35.9 million in cash, cash equivalents, and marketable securities as of September 30, 2024, Lisata expects to be funded through to early 2026, covering the anticipated milestones for all ongoing and planned clinical trials.
The company is focused on advancing its lead investigational therapy certepetide, which is designed to enhance the effectiveness of various anti-cancer treatments in solid tumors by selectively activating a unique transport mechanism, allowing for improved drug delivery to tumors.
David Mazzo, Lisata CEO, said the company is looking forward to a "data-rich 2025."
“Our development portfolio now encompasses multiple clinical and preclinical trials evaluating certepetide for the treatment of various solid tumors, including pancreatic, cholangiocarcinoma, glioblastoma, colon, appendiceal, and melanoma,” Mazzo said.
“In addition, certepetide is being evaluated in a preclinical non-cancerous setting for endometriosis.”
The ASCEND Phase 2b trial is evaluating certepetide in combination with chemotherapy in patients with metastatic pancreatic cancer.
Enrollment was completed in late 2023, with initial data for Cohort A expected at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January 2025. Results for Cohort B are projected by mid-2025 to be followed by a final analysis of both cohorts.
In the BOLSTER Phase 2a trial for cholangiocarcinoma, rapid enrollment six months ahead of schedule has enabled Lisata to anticipate topline data by mid-2025. Enrollment for the second-line cohort is expected to be completed in the first half of 2025.
Additionally, the CENDIFOX trial is studying certepetide in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers, with enrollment in the remaining cohorts expected to conclude by the end of 2024.