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Lisata Therapeutics, Inc. (Nasdaq: LSTA) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. The company's flagship product candidate, LSTA1, is an investigational drug designed to enhance the penetration and targeting of co-administered or tethered anti-cancer drugs into solid tumors through a novel uptake pathway. This mechanism makes LSTA1 a promising adjunct to existing anti-cancer therapies, potentially improving their efficacy.
Lisata's research and development activities leverage its proprietary CendR Platform® Technology, which aims to provide better therapeutic outcomes for patients with challenging solid tumors. The company's core product, LSTA1, has demonstrated favorable safety, tolerability, and promising activity in clinical trials. Significant progress has been made in ongoing Phase 2a and 2b studies targeting a variety of solid tumor types.
Recent achievements for Lisata include:
- A complete response in a patient with metastatic gastroesophageal adenocarcinoma when LSTA1 was combined with standard-of-care treatments.
- The initiation of a Phase 2a study for newly diagnosed glioblastoma multiforme (GBM) across multiple sites in Estonia and Latvia.
- Receiving Orphan Drug Designation (ODD) from the FDA for glioblastoma multiforme and osteosarcoma.
- Securing a Fast Track designation from the FDA for LSTA1 in pancreatic cancer.
- Significant financial milestones achieved, including a reported cash runway extending into early 2026 to support ongoing development efforts.
Financially, Lisata reported operating expenses of $25.7 million for the twelve months ending December 31, 2023, a substantial reduction from $57.6 million in 2022. The company continues to prioritize efficient resource management, ensuring sustained progress in its clinical programs.
Lisata boasts strategic collaborations and commercial partnerships to expand its reach and impact. Its partnership with Qilu Pharmaceutical in Greater China aims to develop LSTA1 for metastatic pancreatic ductal adenocarcinoma (mPDAC). Additionally, the European Medicines Agency (EMA) granted a pediatric investigation plan waiver for LSTA1 in pancreatic cancer, facilitating streamlined regulatory approval processes.
Lisata Therapeutics continues to advance toward its goal of providing breakthrough treatments for patients with advanced solid tumors, positioning itself as a leader in the biopharmaceutical industry.
Lisata Therapeutics (LSTA) announced completion of patient enrollment in all three cohorts of the Phase 1b/2a CENDIFOX trial, evaluating certepetide in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. The investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas Cancer Center, enrolled 66 total patients across three cohorts: 35 with resectable/borderline resectable pancreatic cancer, 18 with high-grade colon and appendiceal cancer with peritoneal metastasis, and 13 with colon cancer with oligo-metastatic disease.
The open-label trial aims to assess safety and therapeutic effects of combining certepetide with neoadjuvant FOLFIRINOX regimens. Results are expected in 2025. The study will provide pre- and post-treatment tumor tissue data for immune profiling and long-term patient outcomes information.
Lisata Therapeutics (NASDAQ: LSTA) and Kuva Labs have announced a global collaboration and license agreement. Kuva gains access to Lisata's certepetide targeting agent to be used with their NanoMark™ MR imaging platform for cancer diagnostics. The partnership aims to create advanced magnetic resonance imaging agents for non-invasive solid tumor detection. Kuva will manage all development and commercialization costs, while Lisata will supply certepetide. The agreement includes an upfront license fee, potential milestone payments, and royalties on future sales for Lisata.
Lisata Therapeutics (NASDAQ: LSTA) has been named 'Specialized BioTherapeutics Company of the Year' at the 2024 BioTech Breakthrough Awards. The company is recognized for its innovative CendR Platform® technology, which enhances tumor-targeted drug delivery. Their lead candidate, certepetide, has shown promising results in pancreatic cancer treatment and holds multiple FDA designations including Fast Track and Orphan Drug status for various cancers.
The company's therapeutic approach focuses on modifying the tumor microenvironment to improve the effectiveness of existing anti-cancer treatments. Certepetide is currently being evaluated in clinical trials for multiple advanced solid tumors, including pancreatic, cholangiocarcinoma, glioblastoma, colon cancer, appendiceal cancer, and melanoma, with potential applications in non-oncologic conditions like endometriosis.
Lisata Therapeutics (LSTA) reported Q3 2024 financial results and provided updates on its development portfolio centered around certepetide, a drug candidate for treating advanced solid tumors. The company reported operating expenses of $5.3 million, down 10.5% year-over-year, and net losses of $4.9 million. Cash position stands at $35.9 million, expected to fund operations into early 2026.
Multiple clinical trials are ongoing, including the Phase 2b ASCEND trial for pancreatic cancer, with preliminary results expected in January 2025. The BOLSTER trial for cholangiocarcinoma achieved complete enrollment ahead of schedule, with topline data expected mid-2025.
Lisata Therapeutics (NASDAQ: LSTA) and Valo Therapeutics have announced a preclinical research collaboration to study the combination of Lisata's certepetide with ValoTx's PeptiCRAd platform and a checkpoint inhibitor in a melanoma mouse model. The study aims to build on previous research showing certepetide's synergistic effects with immunotherapies. ValoTx will conduct the research while Lisata provides the certepetide product. The collaboration targets melanoma treatment, which currently has a 35-60% response rate to checkpoint inhibitor therapies and causes approximately 58,000 deaths annually worldwide.
Lisata Therapeutics (Nasdaq: LSTA), a clinical-stage pharmaceutical company focused on developing therapies for advanced solid tumors and other serious diseases, announced it will release its third quarter 2024 financial results on Tuesday, November 12, 2024, after market close. The company will host a conference call at 4:30 p.m. Eastern time. Participants must pre-register for the call, and a live webcast will be available on Lisata's website, remaining accessible for 12 months after the event.
Lisata Therapeutics (Nasdaq: LSTA), a clinical-stage pharmaceutical company focused on advanced solid tumor treatments, has announced its participation in three major industry events this November. The company will be present at BIO-Europe in Stockholm (Nov 4-6, with virtual sessions Nov 12-13), where VP Tariq Imam will conduct one-on-one meetings. At the PEGS Europe Summit in Barcelona (Nov 5-7), CEO David J. Mazzo will present on Nov 5 at 3:20 p.m. CEST. Additionally, Dr. Mazzo will present at the LSX Inv€$tival showcase in London's Tobacco Dock on Nov 18 at 1:00 p.m. GMT.
Lisata Therapeutics (Nasdaq: LSTA) has entered into a sponsored research agreement with the University of Cincinnati to study certepetide combined with bevacizumab for treating endometriosis. The research aims to leverage certepetide's selective targeting of endometrial tissue through surface integrin and neuropilin-1 receptors. While bevacizumab has shown efficacy in endometriosis treatment, its high dosage requirements cause systemic side effects. The partnership targets endometriosis, a condition affecting 6.5 million U.S. women, characterized by uterine tissue growth outside the uterus, causing pain and fertility issues.
Lisata Therapeutics, Inc. (Nasdaq: LSTA), a clinical-stage pharmaceutical company, has announced its participation in three upcoming industry and investor events in October 2024. These events include:
1. Pharma Partnering U.S. Summit (October 16-17) in Boston, MA, where Tariq Imam, VP of Business Development and Operations, will conduct one-on-one meetings.
2. BioFuture (October 28-30) in New York, NY, featuring a presentation by David J. Mazzo, PhD, President and CEO, on October 28 at 11:00 a.m. ET.
3. 17th Annual LD Micro Main Event (October 28-30) in Los Angeles, CA, where David J. Mazzo will present on October 29 at 11:00 a.m. PT.
These events offer opportunities for investors and industry professionals to learn more about Lisata's innovative therapies for advanced solid tumors and other serious diseases.
Lisata Therapeutics (Nasdaq: LSTA) has announced the treatment of the first patient in the second-line cholangiocarcinoma (CCA) cohort of the BOLSTER trial. This expansion follows the successful completion of enrollment in the first-line CCA cohort. The decision to initiate this cohort was based on recommendations from investigators in the first-line study. The BOLSTER trial is a Phase 2a, double-blind, placebo-controlled, randomized, multi-center study evaluating certepetide in combination with standard-of-care for first- or second-line CCA patients. This expansion aims to improve outcomes for patients who have progressed after first-line standard-of-care therapy alone.
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