Lisata Therapeutics Q2 2024 Financial Results and Business Update

Lisata Therapeutics, Inc., a clinical-stage pharmaceutical company listed on Nasdaq (LSTA), has provided an update on its business activities and financial performance for the second quarter ending June 30, 2024. The company, based in Basking Ridge, New Jersey, continues to focus on developing innovative therapies for advanced solid tumors and other serious diseases, primarily through its novel investigational product, certepetide.

David J. Mazzo, Ph.D., President and CEO of Lisata, highlighted the company's progress in the second quarter, emphasizing the advancement of multiple clinical studies involving certepetide. The company is optimistic about several key data readouts expected within the next 18 months, notably the topline results from the Phase 2b ASCEND trial, which could be transformative for Lisata. In 2024, certepetide received several designations from the U.S. FDA, including Orphan Drug and Rare Pediatric Disease designations for osteosarcoma, and a waiver for pediatric evaluation in pancreatic cancer from the EMA. These recognitions underscore the potential of certepetide as a promising therapeutic option.

Financially, Lisata has managed its resources strategically, projecting that its available funds will support current operations until early 2026. This financial stability will enable the company to complete all planned trials, providing the necessary capital for its continued research and development activities.

Development Portfolio Highlights

Certepetide for Solid Tumors

Certepetide is designed to enhance the delivery and efficacy of co-administered anti-cancer drugs by activating a unique uptake pathway that targets solid tumors. This mechanism allows for more efficient drug penetration and accumulation within tumors, potentially improving therapeutic outcomes. Certepetide has shown promising results in preclinical and clinical studies, including enhanced delivery of various anti-cancer therapies such as immunotherapies and RNA-based drugs. The drug has demonstrated favorable safety and tolerability profiles in clinical trials and is currently being investigated in multiple ongoing and planned Phase 2a and 2b studies globally.

Key Clinical Trials

- ASCEND Trial: This Phase 2b study is evaluating two dosing regimens of certepetide combined with standard-of-care (SoC) chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Conducted across 25 sites in Australia and New Zealand, the trial expects to report topline data from its 95-patient Cohort A by the fourth quarter of 2024, with full data from all 158 patients by mid-2025.

- BOLSTER Trial: A Phase 2a trial in the U.S. assessing certepetide in combination with SoC for cholangiocarcinoma (CCA). The trial achieved full enrollment for first-line CCA faster than anticipated, accelerating the expected topline data readout to mid-2025. A second cohort for second-line CCA patients will begin enrollment by the fourth quarter of 2024.

- CENDIFOX Trial: This Phase 1b/2a study in the U.S. is examining certepetide combined with neoadjuvant FOLFIRINOX therapies for pancreatic, colon, and appendiceal cancers. Enrollment in the pancreatic cohort is complete, with the remaining cohorts expected to finish by the end of 2024.

- iLSTA Trial: A Phase 1b/2a study in Australia evaluating certepetide with the checkpoint inhibitor durvalumab plus SoC chemotherapy for non-resectable pancreatic cancer. Enrollment completion is anticipated in the second half of 2024.

- FORTIFIDE Trial: A U.S.-based Phase 1b/2a trial investigating the safety, tolerability, and efficacy of a continuous infusion of certepetide in combination with SoC for second-line treatment in mPDAC patients. The trial aims to enroll its first patient by the first half of 2025, with exploratory endpoints including circulating tumor DNA levels.

Financial Performance

For the quarter ended June 30, 2024, Lisata reported operating expenses of $5.5 million, a decrease from $6.9 million in the same period in 2023. Research and development expenses were $2.6 million, down from $3.2 million, while general and administrative expenses decreased from $3.7 million to $2.9 million. The company reported a net loss of $5.0 million, compared to $4.0 million in the previous year's second quarter.

As of June 30, 2024, Lisata held $38.3 million in cash, cash equivalents, and marketable securities, which is expected to fund its operations into early 2026.

Conclusion

Lisata Therapeutics continues to advance its clinical programs with a focus on innovative cancer therapies. The company is well-positioned financially to support its ongoing and planned clinical trials, with multiple key data readouts expected in the near future. This progress underscores Lisata’s commitment to developing transformative treatments for patients with advanced solid tumors and other serious diseases.

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