Business Overview and History
Lisata Therapeutics, Inc. (LSTA) is a clinical-stage pharmaceutical company dedicated to developing innovative therapies to address the significant unmet medical needs of patients with advanced solid tumors. The company's lead investigational product, certepetide, is designed to enhance the delivery and penetration of anti-cancer drugs into solid tumors, while also modifying the tumor microenvironment to make it more susceptible to immunotherapies.
Lisata Therapeutics was incorporated in 1980 as a Delaware corporation, focusing on the discovery, development, and commercialization of innovative therapies for the treatment of solid tumors and other major diseases. In its early years, the company established itself as a clinical-stage pharmaceutical company, working to advance its investigational product candidate, certepetide, formerly known as LSTA1 or CEND-1. Through the 2010s, Lisata made significant progress in advancing certepetide through preclinical studies and early-stage clinical trials, demonstrating its potential to enhance the delivery of a range of existing and emerging anti-cancer therapies.
A major milestone in the company's history occurred in 2022 when Lisata Therapeutics acquired Cend Therapeutics, Inc. This acquisition expanded the company's pipeline and provided it with exclusive rights to key intellectual property and know-how related to certepetide. The acquisition solidified Lisata's focus on developing certepetide as a novel approach to treating solid tumors.
Throughout its history, Lisata has faced various challenges common to clinical-stage biotechnology companies, such as securing sufficient capital to fund its research and development activities. The company has utilized a variety of financing methods, including equity issuances and strategic partnerships, to navigate these challenges and advance its programs. Despite the inherent risks and uncertainties of drug development, Lisata has persevered, driven by its mission to address unmet medical needs in oncology and other therapeutic areas.
Certepetide, Lisata's lead product candidate, is a proprietary cyclic peptide that targets the CendR active transport system, allowing it to selectively deliver anti-cancer drugs into solid tumors. Preclinical studies and early-stage clinical trials have demonstrated certepetide's potential to enhance the delivery and efficacy of a range of anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based treatments.
Lisata has made significant progress in advancing certepetide through the clinical development pipeline. The company is currently evaluating the product candidate in several Phase 2 trials across a variety of solid tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), cholangiocarcinoma, glioblastoma multiforme, and colon cancer. These trials are assessing certepetide in combination with standard-of-care therapies, with the goal of improving patient outcomes.
Financial Performance and Liquidity
Financial Performance
Lisata Therapeutics' financial performance has been in line with its clinical-stage status, as the company has prioritized investing in research and development activities to advance its pipeline. For the fiscal year ended December 31, 2024, the company reported total revenue of $1.0 million, which was primarily derived from an upfront license fee related to a collaboration agreement with Kuva Labs, Inc.
Operating expenses for the full year 2024 totaled $23.4 million, a decrease of $2.3 million or 8.9% compared to the prior year. Research and development expenses accounted for $11.3 million, a decrease of $1.4 million or 11% compared to 2023. General and administrative expenses amounted to $12.1 million, a decrease of $0.9 million or 6.9% compared to 2023. The company's net loss for the year was $20.0 million, or $2.40 per diluted share, compared to a net loss of $20.8 million in 2023.
For the most recent quarter (Q3 2024), Lisata reported a net loss of $4.9 million. The company's operating cash flow and free cash flow for the full year 2024 were both negative $19.4 million.
Liquidity
As of December 31, 2024, Lisata had cash, cash equivalents, and marketable securities of $31.2 million, providing a solid runway to fund its ongoing and planned clinical development activities. The company believes this cash position will support current operations into the second quarter of 2026. Lisata's strong financial position is further supported by its ability to raise non-dilutive funding, as evidenced by the $0.9 million in net proceeds generated from the sale of New Jersey net operating losses in early 2025.
Lisata's liquidity metrics as of December 31, 2024, include a debt-to-equity ratio of 0.005, a current ratio of 6.16, and a quick ratio of 6.16. The company had working capital of approximately $29.0 million and stockholders' equity of approximately $29.6 million.
Regulatory Milestones and Pipeline Updates
Lisata's strategy to rapidly advance certepetide through the development pipeline has been bolstered by the receipt of several regulatory designations, including orphan drug designations, a fast track designation, and a rare pediatric disease designation from the U.S. Food and Drug Administration (FDA). These designations are expected to provide the company with various benefits, such as enhanced regulatory support, potential for accelerated approval pathways, and extended market exclusivity.
In January 2025, Lisata reported encouraging preliminary data from the Cohort A of the Phase 2 ASCEND trial, which is evaluating certepetide in combination with standard-of-care chemotherapy in patients with mPDAC. The data showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo group. The company expects to report data from Cohort B of the ASCEND trial in the coming months, with a final analysis of both cohorts to be provided thereafter.
Additionally, Lisata has initiated several other clinical trials to explore the potential of certepetide in a variety of solid tumor types, including the BOLSTER trial in cholangiocarcinoma, the CENDIFOX trial in pancreatic, colon, and appendiceal cancers, and a study in glioblastoma multiforme. The company also recently entered into a preclinical research collaboration with the University of Cincinnati to assess certepetide's potential in the treatment of endometriosis, a non-cancer indication that represents a significant unmet medical need.
Risks and Challenges
As a clinical-stage biopharmaceutical company, Lisata Therapeutics faces several risks and challenges inherent to the industry. The success of the company's lead product candidate, certepetide, is heavily dependent on the outcome of ongoing and future clinical trials. Delays or failures in these trials could significantly impact the company's ability to obtain regulatory approvals and commercialize the product.
Additionally, Lisata's reliance on third-party contract research organizations and manufacturers to conduct its clinical studies and produce its product candidates introduces operational and supply chain risks that could disrupt the company's development timeline. The highly competitive nature of the oncology market also poses a challenge, as Lisata must continue to differentiate its approach and demonstrate the unique benefits of certepetide compared to existing and emerging treatment options.
Lastly, Lisata's financial performance and liquidity position are critical factors that must be closely monitored. The company's ability to secure additional funding, either through capital markets, partnerships, or non-dilutive sources, will be essential to sustaining its operations and advancing its pipeline.
Conclusion
Lisata Therapeutics is at the forefront of developing innovative therapies to address the significant unmet medical needs of patients with advanced solid tumors. The company's lead product candidate, certepetide, has demonstrated promising results in early-stage clinical trials, highlighting its potential to enhance the delivery and efficacy of a range of anti-cancer treatments.
As Lisata continues to advance its robust pipeline, the company's ability to navigate the regulatory landscape, execute on its clinical development strategy, and secure the necessary financial resources will be critical to its long-term success. With a seasoned management team, a growing portfolio of clinical assets, and a strong balance sheet, Lisata is well-positioned to capitalize on the significant opportunities in the oncology market and create value for its shareholders.
The company's focus on certepetide, which activates a novel uptake pathway for more effective targeting and penetration of solid tumors, represents a unique approach in the field of oncology. With multiple ongoing Phase 2 clinical studies across various solid tumor types, Lisata is poised to generate significant data in the coming years that could potentially transform the treatment landscape for patients with difficult-to-treat cancers.
While Lisata faces the inherent risks and challenges of a clinical-stage biopharmaceutical company, its current financial position, with $31.2 million in cash and equivalents as of the end of 2024, provides a runway into the second quarter of 2026. This financial stability, combined with the company's innovative approach and promising clinical data, positions Lisata as an intriguing player in the oncology space for investors and potential partners alike.