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].

BASKING RIDGE, N.J., June 11, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata, will present a corporate overview at the upcoming 2025 BIO International Convention taking place in Boston, MA from June 16 – 19, 2025. Dr. Mazzo’s pre ...

Targeted Therapy Delivered Corporate Presentation | May 8, 2025 Nasdaq: LSTA www.lisata.com © Lisata Therapeutics, Inc. 2025. All rights reserved. Disclosure Forward-looking statements advisory This presentation contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, futur ...

Group 1 - Lisata Therapeutics held its Q1 2025 earnings conference call on May 8, 2025, to discuss financial results and provide a business update [1][3] - The management team present included John Menditto (VP of IR and Corporate Communications), Dr. David Mazzo (President and CEO), Dr. Kristen Buck (EVP of R&D and Chief Medical Officer), and James Nisco (SVP of Finance and Treasury and Chief Accounting Officer) [3][4] - A press release detailing the Q1 2025 financial results was issued shortly before the call, available on the company's website [4]

Financial Data and Key Metrics Changes - Operating expenses for Q1 2025 totaled $5.8 million, a decrease of $800,000 or 11.4% compared to $6.6 million in Q1 2024 [8] - Research and development expenses were approximately $2.6 million for Q1 2025, down from $3.2 million in Q1 2024, representing a decrease of $600,000 or 19.7% [9] - General and administrative expenses were about $3.2 million for Q1 2025, compared to $3.4 million in Q1 2024, a decrease of approximately $100,000 or 3.4% [9] - Net losses were $4.7 million for Q1 2025, compared to $5.4 million for Q1 2024 [9] - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of approximately $25.8 million, expected to support operations into Q3 2026 [10] Business Line Data and Key Metrics Changes - The company is focused on the development of cerdepatide for advanced solid tumors and other difficult-to-treat diseases, with ongoing clinical trials showing promising preliminary results [6][11] - The ASCEND trial is evaluating cerdepatide in combination with standard care for metastatic pancreatic ductal adenocarcinoma, with preliminary results indicating a positive trend in overall survival [15] - The BOLTAR trial for cholangiocarcinoma has completed enrollment ahead of schedule, with a second cohort added for second-line treatment [16] Market Data and Key Metrics Changes - The company continues to face persistent market headwinds for small-cap healthcare companies but maintains strong momentum into 2025 [5] - The ASCEND trial data presented at the ASCO GI symposium reinforced the potential of cerdepatide and the overall development strategy [6] Company Strategy and Development Direction - The company aims to advance cerdepatide as a cornerstone treatment for advanced solid tumors, with several key milestones anticipated in the next 12 to 18 months [7] - Collaborations with other companies, such as Qilu Pharmaceutical and AstraZeneca, are being pursued to enhance the development of cerdepatide [18][22] - The company is exploring additional opportunities to advance its development strategy, including progressing cerdepatide into a global Phase III trial for pancreatic cancer [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformative potential of cerdepatide for patients and significant long-term value for shareholders [26] - The company is focused on prudent capital management and expense minimization while advancing its R&D activities [9][10] Other Important Information - The company has secured multiple special designations from both the FDA and EMA for cerdepatide, enhancing its regulatory position [12] - The company is actively exploring new strategic development opportunities across oncology and other therapeutic areas [22] Q&A Session Summary Question: Impact of capped enrollment in the BOLTAR trial on regulatory path - Management clarified that the BOLTAR trial is not powered to any specific endpoint, and the reduced enrollment will still allow for meaningful data analysis [30] Question: Depth of data analysis for ASCEND presentation - Management indicated that preliminary data will be presented, with definitive data expected at the ESMO GI conference in July [35] Question: Timeline for data from Qilu Pharmaceutical's study - Management noted that they have no control over Qilu's timelines but emphasized the importance of obtaining approval in China before other markets [39] Question: Potential partnerships in endometriosis field - Management stated that discussions are in early stages, with most potential partners currently focused on clinically ready assets [51] Question: Manufacturing capabilities for clinical trials - Management explained that big pharma typically does not function as contract manufacturers for other products unless they have signed deals [43]

Lisata Therapeutics (LSTA) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Welcome to the Losada Therapeutics First Quarter twenty twenty five Financial Results and Business Update Conference Call. Currently, participants are in listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this call is being recorded today, Thursday, 05/08/2025. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications ...