Core Viewpoint - Lisata Therapeutics has formed a strategic collaboration with GATC Health to leverage artificial intelligence in drug discovery, specifically focusing on the lead candidate certepetide and exploring potential new drug combinations [1][2][3] Collaboration Details - GATC Health is recognized for its expertise in AI-driven drug discovery and has been selected by Lloyd's of London for clinical trial insurance, highlighting its credibility [2][3] - The collaboration aims to optimize the development of certepetide for pancreatic cancer and explore its use in combination with other anti-cancer agents or drugs from different therapeutic areas [3][5] Technology and Speed - GATC's technology can perform billions of calculations rapidly, which is expected to accelerate drug development, reduce risks, and lower costs [4] - Both companies emphasize a responsive working relationship, allowing for quick decision-making and implementation [4] Development Strategy - The initial phase involves analyzing certepetide using GATC's advanced technology platform, with future plans to identify other drugs for combination therapy [5][8] - The collaboration is anticipated to enhance Lisata's pipeline by potentially introducing new drug candidates and therapeutic areas [5][6] Clinical Pipeline Progress - Lisata has reported progress in its clinical pipeline, including encouraging preliminary data from the Phase 2b pancreatic cancer trial, which is expected to support the development strategy moving forward [7][10] - The company is also preparing to release data from various trials, including the ASCEND trial, which has shown positive therapeutic effects [9][11] Future Outlook - 2025 is projected to be a data-rich year for Lisata, with expectations for significant clinical data releases and ongoing discussions with regulatory agencies and potential partners to maximize the value of certepetide [9][12]

Company Overview - Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [3] - The company'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] - Lisata has established significant commercial and R&D partnerships based on its CendR Platform technology [3] Upcoming Presentation - David J. Mazzo, Ph.D., President and CEO of Lisata, will present a corporate overview at the Investival Showcase USA on March 11, 2025, at 11:30 a.m. Eastern Time [2] - The conference will take place in Miami, Florida, on March 10-11, 2025 [1] Future Expectations - The company anticipates announcing numerous milestones over the next 1.5 years and believes its projected capital will fund operations into the second quarter of 2026 [3] - This funding will encompass expected data milestones from ongoing and planned clinical trials [3]

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 Insights - The strategic collaboration between Lisata Therapeutics and GATC Health Corp aims to leverage GATC's AI-powered Multiomics Advanced Technology™ platform to optimize and derisk drug discovery and development processes, particularly for Lisata's investigational product, certepetide [1][2][5] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [2][8] - GATC Health Corp is a technology company that utilizes AI to transform drug discovery and development, with its MAT platform simulating billions of biological interactions to enhance drug development efficiency [10] Collaboration Details - The initial phase of the collaboration involves GATC's MAT AI analyzing certepetide to identify optimized development opportunities across various indications, including metastatic pancreatic ductal adenocarcinoma [3][4] - GATC's MAT AI will also explore potential drug combinations with certepetide for various indications beyond oncology [4] - The collaboration is expected to reduce traditional biopharmaceutical risks and enhance the probability of success for drug candidates, leading to more focused studies and shorter development timelines [5][6] Product Focus - Certepetide is designed to activate a novel uptake pathway for anti-cancer drugs, enhancing their ability to target and penetrate solid tumors effectively [9] - The drug has received multiple designations, including Fast Track and Orphan Drug Designation for pancreatic cancer, indicating its potential in treating serious conditions [9] Future Prospects - The collaboration is anticipated to lead to significant milestones over the next 1.5 years, with Lisata expecting its capital to support operations into the second quarter of 2026 [8]

Financial Data and Key Metrics Changes - For the year ended December 31, 2024, revenue totaled $1 million, an increase from $0 in 2023, due to an upfront license fee related to a collaboration agreement [15] - Operating expenses decreased to $23.4 million in 2024 from $25.7 million in 2023, representing a reduction of $2.3 million or 8.9% [15] - Net losses were $20 million in 2024 compared to $20.8 million in 2023, indicating a slight improvement in financial performance [17] - Cash, cash equivalents, and marketable securities as of December 31, 2024, were approximately $31.2 million, expected to support operations into the second quarter of 2026 [18] Business Line Data and Key Metrics Changes - Research and development expenses were approximately $11.3 million in 2024, down from $12.7 million in 2023, a decrease of approximately $1.4 million or 11% [15] - General and administrative expenses decreased to approximately $12.1 million in 2024 from $13 million in 2023, a reduction of approximately $0.9 million or 6.9% [16] Market Data and Key Metrics Changes - The company is actively evaluating the potential of certepetide in various therapeutic areas, including oncology and endometriosis, indicating a broadening of market focus [11][40] Company Strategy and Development Direction - The company is focused on advancing its development portfolio centered around certepetide for treating advanced solid tumors and exploring additional anticancer combinations [9] - Certepetide has received several regulatory designations, including orphan drug and fast track designations, which support its strategic clinical development plan [25] - The company aims to progress certepetide into a Phase 3 study in pancreatic cancer, contingent on data from ongoing trials [43] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2025 being a data-rich year with several key milestones on the horizon [11][46] - The company is committed to prudent capital management while advancing its R&D and business activities [17] Other Important Information - The company received $0.9 million in non-dilutive funding through a tax certificate transfer program, enhancing its financial position [19] - The collaboration with Kuva Labs aims to explore the synergistic potential of certepetide in imaging technology for solid tumors [41][42] Q&A Session Summary Question: Insights on ASCEND trial data from Cohort B - Management expects data from Cohort B to be similar to Cohort A, focusing on progression-free survival and overall survival [50][51] Question: Timing for ASCEND Cohort B data release - Data is anticipated to be available between the second and third quarter of 2025, potentially aligning with major oncology meetings [56][58] Question: Market reaction to Cohort A results - Management noted that the market may have misinterpreted the significance of the results, emphasizing the importance of complete trial data [60][62] Question: Future diagnostics from Kuva deal - The intention is to develop diagnostics that could enhance patient selection for treatment with certepetide [66][68] Question: Expectations from pharmaceutical partners - Partners are looking for complete trial results and consistent therapeutic effects to inform Phase 3 trial design [77][78] Question: Alternative approaches for the FORTIFIDE trial - The company is exploring imaging techniques as a potential alternative to traditional endpoints for the trial [86][87]

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 has a strong emphasis on technology adoption 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]

Revenue and Income - For the year ended December 31, 2024, revenue totaled $1.0 million, an increase from $0 in 2023, attributed to an upfront license fee from Kuva Labs, Inc.[375] - Total other income decreased by approximately $0.9 million or 35.9% to $1.6 million in 2024, primarily due to reduced investment income[377] Expenses and Loss - Total operating expenses decreased by $2.3 million or 8.9% to $23.4 million in 2024 from $25.7 million in 2023, driven by reductions in research and development and general administrative expenses[376] - Net loss for the year ended December 31, 2024, was $19.985 million, a slight improvement from a net loss of $20.840 million in 2023, reflecting a decrease of $855,000[374] Cash Flow and Liquidity - Cash used in operating activities was approximately $19.4 million for 2024, compared to $20.0 million in 2023, indicating a reduction in cash burn[383] - Cash provided by investing activities increased to approximately $13.2 million in 2024 from $10.1 million in 2023, primarily due to net sales of marketable securities[385] - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities of approximately $31.2 million, with working capital of approximately $29.0 million[380] - The company expects to meet its short and long-term liquidity needs through existing cash balances and potential issuances of debt or equity securities[389] Clinical Studies - The company is currently conducting several Phase 2 clinical studies globally for its investigational product, certepetide, targeting various solid tumors[372] Stock Issuance - The company issued 3,779 shares of common stock under the ATM Agreement for net proceeds of $10,074 during the twelve months ended December 31, 2024[391]

Revenue - For the year ended December 31, 2024, revenue totaled $1.0 million from an upfront license fee related to the Exclusive License and Collaboration Agreement with Kuva Labs, Inc., compared to no revenue in 2023[9] - Revenue for the twelve months ended December 31, 2024, was $1,000, compared to $0 in 2023[22] Operating Expenses - Operating expenses for 2024 were $23.4 million, a decrease of $2.3 million or 8.9% from $25.7 million in 2023[9] - Total operating expenses for 2024 were $23,409, a decrease of 9% from $25,708 in 2023[22] Research and Development Expenses - Research and development expenses were approximately $11.3 million in 2024, down 11.0% from $12.7 million in 2023, primarily due to reduced expenses associated with the Phase 2b ASCEND trial[10] - Research and development expenses decreased to $11,334, down from $12,734 in 2023, representing a reduction of approximately 11%[22] General and Administrative Expenses - General and administrative expenses were approximately $12.1 million in 2024, a decrease of 6.9% from $13.0 million in 2023[11] - General and administrative expenses decreased to $12,075, down from $12,974 in 2023, a decrease of about 7%[22] Net Loss - Net losses for the years ended December 31, 2024, and 2023 were $20.0 million and $20.8 million, respectively[12] - The net loss attributable to Lisata Therapeutics, Inc. common stockholders for 2024 was $19,985, compared to a net loss of $20,840 in 2023, reflecting a reduction of approximately 4%[22] - Basic and diluted loss per share attributable to common stockholders improved to $2.40 in 2024 from $2.58 in 2023[22] Cash and Assets - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled approximately $31.2 million, supporting operations into the second quarter of 2026[13] - Cash, cash equivalents, and marketable securities decreased to $31,245 as of December 31, 2024, down from $50,535 in 2023, a decline of approximately 38%[22] - Total assets decreased to $35,002 in 2024 from $54,694 in 2023, a reduction of about 36%[22] - Total liabilities decreased to $5,685 in 2024 from $6,800 in 2023, a decrease of approximately 16%[22] - Total equity decreased to $29,317 in 2024 from $47,894 in 2023, reflecting a decline of about 39%[22] Clinical Trials and Collaborations - Certepetide has shown a positive trend in overall survival in the ASCEND trial, with four complete responses in the treatment group compared to none in the placebo group[4] - Enrollment in the BOLSTER trial for first-line cholangiocarcinoma was completed nearly six months ahead of schedule, with topline data expected in mid-2025[7] - Lisata has entered into multiple research collaborations, including a partnership with Valo Therapeutics to investigate the combination of certepetide with their platform technology for melanoma treatment[6] Funding - The company received $0.9 million in non-dilutive funding through the Technology Business Tax Certificate Transfer Program, selling $19.6 million in tax benefits for net proceeds of $18.4 million[14]

Core Insights - Lisata Therapeutics is advancing its development portfolio centered around its product candidate, certepetide, with promising preliminary Phase 2b data for pancreatic cancer and multiple upcoming milestones expected over the next 12+ months [1][3][4] Development Portfolio Highlights - Certepetide is designed to enhance the delivery of anti-cancer agents to solid tumors and has shown favorable safety and clinical activity in trials [4][18] - The ASCEND trial, a Phase 2b study, has completed enrollment with 95 patients, showing a positive trend in overall survival and four complete responses in the treatment group [4][6] - Cohort B data from the ASCEND trial is anticipated in the coming months, with a total of 63 patients involved [4][5] - Other ongoing trials include BOLSTER for cholangiocarcinoma, CENDIFOX for pancreatic and colon cancers, and iLSTA for non-resectable pancreatic cancer, with data expected in mid-2025 [6][10][12] Financial Highlights - For the year ended December 31, 2024, Lisata reported revenue of $1.0 million, a decrease in operating expenses to $23.4 million from $25.7 million in 2023, and a net loss of $20.0 million [9][10][12] - Research and development expenses decreased to approximately $11.3 million, while general and administrative expenses were approximately $12.1 million [10][11] - As of December 31, 2024, the company had cash and marketable securities of approximately $31.2 million, which is expected to support operations into the second quarter of 2026 [13][18] Collaborations and Agreements - Lisata has entered into a collaboration with Kuva Labs to explore the use of certepetide in conjunction with imaging technology, receiving a $1.0 million upfront license fee and potential milestone payments [8][9] - The company is also collaborating with the University of Cincinnati and Valo Therapeutics for various studies involving certepetide [6][7]

Group 1 - Lisata Therapeutics, Inc. will report its financial results for the twelve months ended December 31, 2024, on February 27, 2025, after market close [1] - A conference call will be hosted at 4:30 p.m. Eastern time on the same day, with registration required for participation [2] - A live webcast of the call will be available on Lisata's website and will be accessible for replay for 12 months after the call [3] Group 2 - Lisata Therapeutics is focused on developing innovative therapies for advanced solid tumors and other serious diseases, with its lead product candidate, certepetide, designed to enhance the targeting of anti-cancer drugs [4] - The company has established significant commercial and R&D partnerships based on its CendR Platform® technology and anticipates announcing multiple milestones over the next 1.5 years [4] - Lisata expects its projected capital to fund operations into the second quarter of 2026, covering anticipated data milestones from ongoing and planned clinical trials [4]