BASKING RIDGE, N.J. - Lisata Therapeutics, Inc. (NASDAQ:LSTA), a clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational drug, certepetide, for the treatment of cholangiocarcinoma, a rare and aggressive form of cancer. This designation aims to facilitate drug development for rare diseases and conditions, affecting fewer than 200,000 people in the United States.
Certepetide is currently being evaluated in the BOLSTER trial, a Phase 2a study for the treatment of first- and second-line cholangiocarcinoma. This double-blind, placebo-controlled, multi-center, randomized study is taking place in the United States and is part of the company's efforts to address the significant challenge posed by limited treatment options for this condition.
Orphan Drug Designation by the FDA can provide several benefits to the sponsor, including seven years of exclusive marketing rights post-approval, exemption from user fees, and eligibility for tax credits for qualified clinical trials. It often leads to closer collaboration with the FDA, which may shorten clinical development timelines.
Cholangiocarcinoma, also known as bile duct cancer, has a five-year survival rate under 5%, underscoring the urgent need for innovative treatments. Certepetide has been designed to selectively activate a novel uptake pathway, potentially allowing co-administered anti-cancer drugs to target and penetrate solid tumors more effectively.
Lisata Therapeutics focuses on developing therapies for advanced solid tumors and other serious diseases. The company has previously received Fast Track designation for certepetide as well as Orphan Drug Designation for pancreatic cancer in the U.S. and E.U., and for glioma, osteosarcoma, and cholangiocarcinoma in the U.S. Rare Pediatric Disease Designation for osteosarcoma has also been granted in the U.S.
The company believes that its projected capital will support operations into early 2026, which encompasses anticipated data milestones from ongoing and planned clinical trials. This announcement is based on a press release statement from Lisata Therapeutics.
In other recent news, Lisata Therapeutics reported its second-quarter financial results for 2024, including a net loss of $5 million. The company's earnings per share (EPS) stood at ($0.61), outpacing both H.C. Wainwright's estimate of ($0.76) and the consensus of ($0.75). Operating expenses decreased, with research and development costs dropping to $2.6 million from $3.2 million, and general and administrative expenses reducing to $2.9 million from $3.7 million.
H.C. Wainwright maintained a Buy rating on Lisata's shares, keeping the price target steady at $15.00. This decision followed the company's recent advancements, including the progress of its lead candidate, certepetide, through multiple clinical trials.
Lisata Therapeutics ended the quarter with $38.3 million in cash, which is expected to support all ongoing and proposed trials up until early 2026. The company's investigational product, Certepetide, is under multiple clinical trials for treating advanced solid tumors and has received fast track and orphan drug designations. Top-line data from the ASCEND trial for Certepetide is anticipated in Q4 of 2024. These are among the recent developments within Lisata Therapeutics.
InvestingPro Insights
As Lisata Therapeutics, Inc. (NASDAQ:LSTA) receives the FDA's Orphan Drug Designation for certepetide, investors may be considering the financial health and future prospects of the company. According to real-time data from InvestingPro, Lisata Therapeutics currently holds a market capitalization of $24.96 million. This valuation reflects investor sentiment and the company's perceived potential, particularly in light of recent developments.
InvestingPro Tips suggest that Lisata Therapeutics holds more cash than debt on its balance sheet, which could provide financial flexibility as it continues to develop certepetide. Moreover, the company's liquid assets exceed short-term obligations, indicating a stable short-term financial position that could support ongoing clinical trials. However, analysts have raised concerns about the company's profitability, noting that Lisata Therapeutics has not been profitable over the last twelve months and does not expect to turn a profit this year. Additionally, the company's gross profit margins are considered weak, which could impact its ability to generate returns on investments.
From a stock performance perspective, the price of Lisata Therapeutics has had a mixed trajectory, with a one-year price total return of 36.36%, yet the price has generally performed poorly over the last decade. The company does not pay a dividend to shareholders, which may influence investment decisions for those seeking regular income. For a deeper analysis and more InvestingPro Tips, interested parties can explore the full range of insights available on the InvestingPro platform, which includes additional tips for a comprehensive investment strategy.
Investors should note that the company's next earnings date is scheduled for November 7, 2024, which will provide further insights into Lisata Therapeutics' financial performance and the progress of certepetide. Moreover, the fair value estimates range from $3.63, according to InvestingPro's fair value assessment, to analyst targets of $14.5, suggesting a divergence in valuation perspectives that investors may want to consider.
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