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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 (NASDAQ: LSTA) has reported its full year 2024 financial results and provided updates on its development portfolio. The company's primary focus is on certepetide, a novel treatment for advanced solid tumors. Key highlights include promising preliminary Phase 2b (ASCEND) pancreatic cancer data from Cohort A, with Cohort B data expected in coming months.
Financial results show revenue of $1.0 million from a Kuva Labs licensing agreement, while operating expenses decreased 8.9% to $23.4 million. Net losses were $20.0 million for 2024, compared to $20.8 million in 2023. The company maintains a strong financial position with $31.2 million in cash and equivalents, providing runway into Q2 2026.
Multiple clinical trials are advancing, including ASCEND, BOLSTER, CENDIFOX, and iLSTA, evaluating certepetide across various cancer types. The company received $0.9 million in non-dilutive funding through New Jersey's Tax Certificate Transfer Program.
Lisata Therapeutics (LSTA), a clinical-stage pharmaceutical company focused on advanced solid tumor treatments, has scheduled its full year 2024 financial results announcement for Thursday, February 27, 2025, 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 attendees will receive dial-in details via email. To ensure smooth participation, attendees are encouraged to dial in 15 minutes before the scheduled start time. A live webcast will be available on Lisata's website under the Investors & News section, with a replay accessible for 12 months after the call.
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 participation in the upcoming 2025 BIO CEO & Investor Conference.
The company's President and CEO, David J. Mazzo, PhD, will deliver a corporate overview presentation on Monday, February 10th at 2:00 p.m. Eastern Time. The conference is scheduled to take place from February 10-11, 2025, at the New York Marriott Marquis in New York City.
Lisata Therapeutics (NASDAQ: LSTA) and WARPNINE announced encouraging preliminary results from their Phase 1b/2a iLSTA trial evaluating certepetide in combination with standard-of-care (SoC) chemotherapy and immunotherapy for locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC).
The trial, conducted at St John of God Subiaco Hospital, involved 30 patients in three cohorts. Key preliminary results from 17 patients showed:
- 9 of 16 patients achieved partial response after 4 treatment cycles
- 1 patient exhibited complete response
- 14 of 17 patients showed decreased CA19-9 levels, with 6 patients showing >90% reduction
- All 5 analyzed patients showed significant immune cell infiltration (15% to 50%)
The data suggests certepetide's potential to enhance the effectiveness of various cancer treatments when combined with SoC chemotherapy and immunotherapy.
Lisata Therapeutics (NASDAQ: LSTA) announced preliminary Cohort A data from its Phase 2 ASCEND trial evaluating certepetide with standard chemotherapy in metastatic pancreatic ductal adenocarcinoma. The trial, conducted across 25 sites in Australia and New Zealand, showed encouraging results with a median overall survival of 12.68 months in the certepetide group versus 9.72 months in the placebo group.
The study reported 4 complete responses (6.2%) in the certepetide treatment group compared to none in the placebo group. While the 6-month progression-free survival showed a numerical trend favoring certepetide, both groups had a median PFS of 5.5 months. The trial includes two cohorts: Cohort A with 95 patients receiving a single dose, and Cohort B with 63 patients receiving two doses of certepetide. Data from Cohort B is expected in the coming months, with plans to advance to Phase 3 in early 2026.
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 participation in the upcoming 2025 Sequire Investor Summit in San Juan, Puerto Rico.
The company's President and CEO, David J. Mazzo, PhD, will deliver a corporate overview presentation on Wednesday, January 22, 2025, at 10:00 a.m. Atlantic Standard Time. The summit is scheduled to take place from January 21-23, 2025.
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.
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