Lisata Therapeutics, Inc. (NASDAQ:LSTA) has seen its stock surge over 30% year-to-date, driven by positive developments with its lead pipeline candidate, certepetide. The company's innovative approach to enhancing the delivery and efficacy of cancer therapies has garnered significant attention from the investment community. However, Lisata still faces several challenges as it navigates the complex landscape of oncology drug development.
Business Overview
Lisata is a clinical-stage pharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of solid tumors and other major diseases. The company's lead investigational product candidate, certepetide, is designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively.Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, while normal tissues are expected to be unaffected. Certepetide also has been shown to modify the tumor microenvironment, thereby making tumors more susceptible to immunotherapies and inhibiting the metastasis cascade.
Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability and activity in completed and ongoing clinical trials designed to enhance delivery of standard-of-care chemotherapy for pancreatic cancer.
Financials
Lisata's financial performance has been characterized by consistent net losses and a lack of revenue. For the fiscal year 2023, the company reported a net loss of $20.8 million and no revenue. The company's annual operating cash flow and free cash flow were both -$20.0 million.In the first quarter of 2024, Lisata reported a net loss of $5.4 million, compared to a net loss of $6.2 million in the same period of the prior year. The company's research and development expenses were approximately $3.2 million in Q1 2024, relatively unchanged from the $3.2 million reported in Q1 2023. General and administrative expenses decreased from $3.7 million in Q1 2023 to $3.4 million in Q1 2024, primarily due to a reduction in staffing costs and other administrative expenses.
As of March 31, 2024, Lisata had cash, cash equivalents and marketable securities of approximately $43.3 million, which the company believes will fund operations into early 2026, encompassing anticipated data milestones from all its ongoing and currently planned clinical trials.
Regulatory Designations and Clinical Pipeline
Lisata has worked diligently to optimize its regulatory strategy for certepetide, which has resulted in the product candidate receiving several special designations from the FDA. These include a Fast Track designation for pancreatic cancer, Orphan Drug designations for pancreatic cancer, glioblastoma multiforme, and osteosarcoma, as well as a Rare Pediatric Disease Designation for osteosarcoma.Certepetide is currently the subject of several Phase 2 clinical studies being conducted globally in a variety of solid tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), cholangiocarcinoma, appendiceal cancer, colon cancer and glioblastoma multiforme in combination with a variety of anti-cancer regimens.
The ASCEND trial, a 158-patient double-blind, placebo-controlled randomized clinical trial evaluating certepetide in combination with standard-of-care chemotherapy in patients with mPDAC, is a key focus for the company. The trial has completed enrollment, and Lisata expects to report top-line data from the first 95 patients in the fourth quarter of 2024, with the full dataset expected by mid-2025.
Additionally, the BOLSTER trial, a Phase 2a study evaluating certepetide in combination with standard-of-care in first-line cholangiocarcinoma, has made significant enrollment progress and is expected to complete enrollment by the end of 2024, if not sooner. Lisata is also considering initiating a BOLSTER study amendment to evaluate certepetide in second-line cholangiocarcinoma.
Risks and Challenges
Despite the promising developments with certepetide, Lisata faces several risks and challenges. The company's history of operating losses and liquidity challenges may make it difficult to raise additional capital on acceptable terms, which could materially and adversely affect its business operations.Additionally, the success of Lisata's clinical trials is critical to the company's future, and any delays or failures in these trials could significantly impact the company's prospects. The competitive landscape in oncology is also highly dynamic, and Lisata will need to continue to differentiate certepetide and demonstrate its superiority over existing and emerging therapies.
Outlook
Lisata's leadership team remains optimistic about the future of certepetide and the company's ability to address significant unmet medical needs in solid tumor cancers. The anticipated data readouts from the ASCEND and BOLSTER trials in the coming years will be crucial in determining the product candidate's path forward and the company's ability to secure partnerships or additional funding.If the clinical data continues to demonstrate certepetide's ability to enhance the delivery and efficacy of various cancer therapies, Lisata could be well-positioned to disrupt the standard of care in several solid tumor indications. However, the company will need to navigate the complex regulatory landscape and secure the necessary resources to advance certepetide through late-stage development and potential commercialization.