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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), a clinical-stage pharmaceutical company, has announced its participation in two major industry events in September 2024. The company will be part of the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, with an on-demand virtual presentation available from September 9. Additionally, Lisata will present at the 2024 LSX World Congress USA on September 12 at 11:15 a.m. ET in Boston.
Dr. David J. Mazzo, President and CEO of Lisata, will be the presenter at both events. These conferences provide Lisata with opportunities to showcase its innovative therapies for advanced solid tumors and other serious diseases to investors and industry professionals.
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.
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