Welcome to our dedicated page for Lisata Therapeutics news (Ticker: LSTA), a resource for investors and traders seeking the latest updates and insights on Lisata Therapeutics stock.
Lisata Therapeutics, Inc. (Nasdaq: LSTA) is a clinical-stage pharmaceutical company developing certepetide-based therapies for advanced solid tumors and other serious diseases. This news page aggregates company announcements, clinical trial updates and regulatory disclosures so readers can follow how Lisata’s certepetide program and related partnerships evolve over time.
Lisata’s recent news flow has focused on progress across multiple certepetide clinical studies, including the ASCEND Phase 2b trial in metastatic pancreatic ductal adenocarcinoma, the BOLSTER Phase 2a trial in cholangiocarcinoma, the CENDIFOX Phase 1b/2a trial in pancreatic, colon and appendiceal cancers, the iLSTA Phase 1b/2a trial in locally advanced non-resectable pancreatic ductal adenocarcinoma and a Phase 2a glioblastoma multiforme study. Press releases have highlighted preliminary efficacy and safety signals, tumor microenvironment findings and timelines for upcoming data readouts.
Investors and researchers can also see updates on Lisata’s business development activities, such as its global non-exclusive license agreement with Catalent, Inc. to use certepetide as a SMARTag® antibody-drug conjugate payload, and its strategic alliance with GATC Health to apply an AI-powered Multiomics Advanced Technology™ platform to drug discovery. Financial results releases provide context on operating expenses, cash runway and the company’s ability to support ongoing trials.
By reviewing the LSTA news feed on this page, readers can monitor clinical milestones, conference presentations, licensing developments and other corporate communications directly sourced from Lisata’s public announcements and related SEC-referenced materials.
Lisata Therapeutics (Nasdaq: LSTA) has received FDA Orphan Drug Designation for certepetide in treating cholangiocarcinoma, a rare and aggressive cancer. This designation is a significant step towards addressing the unmet need for new therapies in this area. Lisata is currently conducting the BOLSTER trial, a Phase 2a study evaluating certepetide for first- and second-line cholangiocarcinoma treatment. The trial is a double-blind, placebo-controlled, multi-center, randomized study taking place in the U.S. This development underscores Lisata's commitment to developing innovative therapies for advanced solid tumors and other serious diseases.
Lisata Therapeutics (LSTA) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Phase 2b ASCEND trial top-line data for certepetide in metastatic pancreatic cancer expected in Q4 2024.
2. Available cash projected to fund operations into early 2026, covering all active studies.
3. Multiple ongoing Phase 2 trials for certepetide in various solid tumors.
4. Q2 2024 operating expenses decreased by 19.7% to $5.5 million compared to Q2 2023.
5. Net loss of $5.0 million for Q2 2024, compared to $4.0 million in Q2 2023.
6. Cash, cash equivalents, and marketable securities of $38.3 million as of June 30, 2024.
Lisata Therapeutics (Nasdaq: LSTA), a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases, has announced its plans to report second quarter 2024 financial results on Monday, August 12, 2024, after market close. The company will host a conference call at 4:30 p.m. Eastern time to discuss the results and provide a business update.
Participants must pre-register for the conference call through a provided link. Registered participants will receive email instructions with dial-in options. To ensure a smooth experience, participants are encouraged to dial in 15 minutes before the scheduled start time. Additionally, a live webcast of the call will be available on Lisata's website under the Investors & News section, with a replay accessible for 12 months following the call.
Haystack Oncology, a Quest Diagnostics company, and Lisata Therapeutics (Nasdaq: LSTA) have announced a research collaboration to evaluate the efficacy of a pancreatic cancer therapy. Lisata will use Haystack's MRD™ technology to detect circulating tumor DNA (ctDNA) in a clinical study of certepetide plus chemotherapy for metastatic pancreatic cancer.
The collaboration is part of the FORTIFIDE study, which investigates certepetide's safety, tolerability, and efficacy in combination with standard treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). Haystack's technology will measure serum ctDNA levels throughout the study as an exploratory endpoint to analyze certepetide's early therapeutic effect.
This collaboration aims to address the challenge of early response measurement in pancreatic cancer treatment development, potentially offering a more sensitive alternative to conventional imaging assessments.
Lisata Therapeutics (Nasdaq: LSTA) has announced the early completion of enrollment in its Phase 2a BOLSTER trial for certepetide, a potential treatment for first-line cholangiocarcinoma (CCA). The trial, which finished enrollment nearly six months ahead of schedule, is evaluating certepetide in combination with standard-of-care versus standard-of-care alone. Due to the rapid enrollment and urgent need for improved treatments, Lisata has added a second-line CCA arm to the trial, with the first patient expected to enroll by Q4 2024. Top-line data from the first-line cohort is now anticipated by mid-2025, potentially accelerating the development of this novel therapeutic approach for CCA.
Lisata Therapeutics announced promising preclinical results for its investigational candidate, certepetide, in treating intrahepatic cholangiocarcinoma. Presented by Dr. Dan G. Duda at the 2024 Cholangiocarcinoma Foundation Annual Conference, the study showed that certepetide combined with standard chemotherapy and immunotherapy improved survival in mice, reduced metastasis, and enhanced immune cell infiltration into tumors. Lisata is conducting a Phase 2a clinical trial (BOLSTER) to evaluate certepetide with standard chemotherapy as a first-line treatment and will soon add an arm to test it with chemoimmunotherapy. Results are expected in 2025.
Lisata Therapeutics announced the successful completion of patient enrollment for the pancreatic cancer cohort in their Phase 1b/2a CENDIFOX trial. This trial, conducted at the University of Kansas Cancer Center, is assessing the safety and efficacy of combining certepetide with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. A total of 51 patients will be enrolled, and the study will provide valuable pre- and post-treatment tumor tissue data for immune profiling. The trial is funded by the KU Cancer Center, with Lisata supplying certepetide. The company is looking forward to completing enrollment in the remaining cohorts and reporting results.
Lisata Therapeutics, a clinical-stage pharmaceutical company developing therapies for advanced solid tumors and other serious diseases, announced its participation in two key industry events in June 2024.
CEO David J. Mazzo will present at the BIO International Convention in San Diego on June 3 at 2:15 p.m. PT. The company will also participate in the virtual GCFF 2024 Bio Investing Conference on June 20 at 10:00 a.m. PT. Both events will feature presentations by Mazzo and opportunities for one-on-one meetings with attendees.
Lisata Therapeutics announced that the European Medicines Agency (EMA) has granted a Paediatric Investigation Plan (PIP) waiver for its lead investigational product, certepetide, in pancreatic cancer.
The waiver, recommended by the EMA's Paediatric Committee (PDCO), confirms that pediatric studies for certepetide are unnecessary as pancreatic cancer occurs only in adults.
This decision allows Lisata to avoid the significant clinical trial burden and costs associated with pediatric studies, focusing instead on expediting therapy development for adults with pancreatic cancer.
The waiver will not impact Lisata's commitment to evaluating certepetide in other pediatric solid tumors as required.
Lisata Therapeutics, Inc. reported strong first-quarter 2024 financial results and provided an update on its business activities. The company is anticipating pivotal data readouts from the Phase 2b ASCEND trial later in 2024, with transformative potential. They have received significant regulatory designations for their investigational drug certepetide in various cancer types. Lisata's financial management allows operations to be funded until early 2026. The company is executing multiple ongoing and planned clinical trials globally to advance their innovative therapies.