Core Insights - Lisata Therapeutics and WARPNINE have completed patient enrollment in the Phase 1b/2a iLSTA trial, evaluating certepetide in combination with standard-of-care chemotherapy and immunotherapy for locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC) [1][2] - The trial is significant as it targets an earlier stage of PDAC, where immunotherapy has been largely ineffective [2] - Preliminary data from the trial presented at ESMO-GI indicated a 60% overall response rate and a 100% overall disease control rate after four treatment cycles [3][4] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [7] - Certepetide, the company's proprietary product candidate, is designed to enhance the delivery of anti-cancer drugs to solid tumors and has shown favorable safety and clinical activity in trials [6][7] - The company has received multiple designations for certepetide, including Fast Track and Orphan Drug Designations for pancreatic cancer in the U.S. and E.U. [6] Trial Details - The iLSTA trial is randomized, single-blind, and conducted at St John of God Subiaco Hospital, a leading center for clinical research in Australia [2][3] - Participants were divided into three cohorts, with varying combinations of standard-of-care chemotherapy and immunotherapy [2] - The trial aims to assess the efficacy of certepetide in improving treatment outcomes for patients with locally advanced PDAC [2][4] Preliminary Data Highlights - After four treatment cycles, 13 out of 20 participants showed a partial response, and one participant exhibited a complete response [3] - 16 out of 20 participants experienced a decrease in CA19-9 levels, a tumor marker, with several showing significant reductions [3] - No participants showed an increase in tumor size, indicating a positive response to the treatment [3] Collaboration and Support - The collaboration between Lisata and WARPNINE combines global expertise with local clinical execution to address urgent needs in pancreatic cancer treatment [2] - AstraZeneca is involved in providing drug supply, enhancing the trial's operational capabilities [2] - The successful completion of patient enrollment reflects the commitment of both organizations to advance treatment options for patients with PDAC [4]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Points - Lisata Therapeutics has received a new composition of matter patent for certepetide, extending IP protection until March 2040, with potential for further extension [1][2] - The patent secures exclusive rights to certepetide, preventing others from manufacturing or selling the drug, thus significantly enhancing the company's IP portfolio [2][3] - The CEO of Lisata highlighted that this patent milestone boosts the value of certepetide and the company, delaying generic competition for nearly two decades and supporting commercialization efforts [3] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [5] - Certepetide is designed to enhance the delivery of anti-cancer drugs to solid tumors by activating a novel uptake pathway, showing promise in improving treatment efficacy [4][5] - The company has established significant partnerships and expects to announce multiple milestones in the next 1.5 years, with sufficient capital projected to fund operations into Q4 2026 [5]

Core Insights - Lisata Therapeutics is deepening its collaboration with GATC Health, leveraging complementary strengths in clinical and regulatory expertise alongside AI-powered drug discovery [1][2] - The partnership aims to develop opioid use disorder (OUD) candidates, addressing a significant unmet medical need in the U.S. [3][6] - The MAT platform from GATC Health enhances drug development efficiency by predicting drug performance and identifying potential failures early [4][5] Company Collaboration - The partnership has evolved due to the effective collaboration between Lisata's clinical experience and GATC's bioinformatics capabilities [2] - The focus on OUD as the first joint development target is due to the availability of high-quality addiction data and the identification of novel targets linked to OUD [6] Drug Development Process - Traditional drug development is inefficient, often requiring extensive testing; the MAT platform aims to streamline this process by using AI to prioritize promising candidates [4] - The MAT platform acts as a forecasting tool, allowing for informed decision-making and reducing resource waste [5] Market Potential - The OUD market represents a multibillion-dollar opportunity in North America, with potential for significant revenue through licensing and milestone payments if the drug is successful [9] - The collaboration model between AI firms and biotech companies is expected to become more common, as it allows for innovative approaches to drug development [10]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - The ASCEND Phase 2b trial shows promising preliminary data for certepetide in treating metastatic pancreatic cancer, with positive signals in progression-free survival and objective response rates compared to placebo [1][2][6] - Cohort B data supports the findings from Cohort A, indicating a treatment effect and an attractive safety profile for certepetide [1][6][8] - Full study data from both cohorts is expected later this year, which may provide further insights into the efficacy of certepetide [7] Study Design and Results - The ASCEND trial is a double-blind, randomized, placebo-controlled study involving 158 patients, comparing standard-of-care gemcitabine and nab-paclitaxel with or without certepetide [3] - Cohort A utilized a single dose of 3.2 mg/kg of certepetide, while Cohort B included an additional dose administered four hours later [3] - Preliminary results from Cohort B indicate a six-month progression-free survival of 60.8% for the certepetide group versus 25% for the placebo group, with median progression-free survival of 7.5 months compared to 4.7 months [5] Clinical Significance - The addition of certepetide resulted in a clinically meaningful improvement in both progression-free survival and objective response rates for patients with metastatic pancreatic ductal adenocarcinoma [6] - The objective response rate was 45.2% for the certepetide group compared to 19% for the placebo group, and median overall survival was 10.32 months versus 9.23 months [5] Industry Context - Pancreatic cancer has a poor prognosis, being the sixth leading cause of cancer mortality globally, with a five-year survival rate of only 13%, highlighting the need for new treatment options [9] - Certepetide is designed to enhance the delivery of anti-cancer drugs to solid tumors and has shown favorable safety and tolerability in clinical trials [12][13]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - The strategic alliance between Lisata Therapeutics and GATC Health aims to enhance drug development success rates by leveraging GATC's AI-powered Multiomics Advanced Technology® platform, with a focus on advancing a therapeutic for opioid use disorder into human clinical trials by early 2026 [1][3][4]. Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and serious diseases, with a notable product candidate, certepetide, designed to improve targeting of solid tumors [8]. - GATC Health Corp. is a technology company that utilizes AI to transform drug discovery and development, with its MAT platform capable of simulating human biochemistry to create novel therapeutics and predict drug efficacy and safety [9][11]. Collaboration Details - The collaboration builds on previous work where GATC provided AI-derived analysis for Lisata's certepetide candidate, and under the expanded relationship, Lisata will utilize GATC's MAT platform to identify new combination therapies across various therapeutic areas [2][3]. - Lisata will lead the development of a non-opioid small molecule candidate for opioid use disorder, which has shown significant efficacy in preclinical studies by reducing fentanyl intake in animal models [3][12]. Financial and Strategic Implications - The partnership is expected to create substantial value for the pharmaceutical industry, with predictions suggesting AI technologies could generate $350 to $400 billion by the end of 2025, while also significantly shortening the drug discovery timeline [4]. - GATC will cover all R&D costs for its development assets, while Lisata will receive milestone fees and royalties from any successfully commercialized products, indicating a financially symbiotic relationship [7]. Technology Validation - GATC's MAT platform has demonstrated high predictive accuracy, with sensitivity at 86% and specificity at 91%, validated by the University of California, Irvine, positioning it to meet FDA requirements for new methodologies prioritizing human-relevant data [5][11].

Core Insights - Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [1][3] - The company will present a corporate overview at the 2025 BIO International Convention in Boston, scheduled for June 17, 2025 [1][2] Company Overview - Lisata's lead product candidate, certepetide, is designed to activate a novel uptake pathway for more effective targeting and penetration of solid tumors by anti-cancer drugs [3] - The company has established significant commercial and R&D partnerships based on its CendR Platform technology [3] - Lisata anticipates announcing multiple milestones over the next 1.5 years and expects its capital to fund operations into Q3 2026, covering anticipated data milestones from ongoing and planned clinical trials [3]

Company Overview - Lisata Therapeutics is a clinical-stage therapeutics company developing a novel solid tumor targeting and penetration technology with tumor microenvironment (TME) modifying properties[7] - The company's mission is to enhance the treatment benefits of existing and emerging therapies for solid tumors without additional side effects[9] - Lisata has a cash runway extending into 3Q2026 with no debt, funding current clinical programs[11] Certepetide Technology and Partnerships - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing TME immunosuppression, inhibiting metastasis, and working with any modality of anti-cancer therapeutics[23] - Lisata has existing partnerships with Qilu Pharmaceutical, Kuva Labs, and Valo Therapeutics, with potential for additional partnerships[25] - Qilu granted exclusive rights in China, Taiwan, Hong Kong and Macau, Lisata collected $15 million in milestones to date, with potential for additional $221 million in milestones plus royalties[27] Clinical Development and Regulatory Designations - Certepetide has FDA Fast Track Designation for pancreatic cancer, potentially eligible for Accelerated Approval, Priority Review and Rolling Review[93] - Certepetide has FDA Rare Pediatric Disease Designation for Osteosarcoma, eligible for Priority Review Voucher upon approval, vouchers have sold recently for $75-$100 million[94] - Lisata is pursuing rapid global registration in mPDAC, initially combined with gemcitabine/nab-paclitaxel standard-of-care (SoC)[67] Clinical Trial Data - Two Phase 1 clinical trials (CEND1-001 in Australia and CEND1-201 in China) demonstrate that certepetide plus SoC chemotherapy improves overall survival in metastatic PDAC[90] - ASCEND Phase 2 trial Cohort A data demonstrate positive trend in overall survival, including 4 complete responses observed in certepetide treatment group compared to none in placebo group[90] - In ASCEND Phase 2 trial Cohort A, the median overall survival was 1268 months for the Certepetide arm compared to 972 months for the Placebo arm[86]