Core Insights - Lisata Therapeutics is making significant progress in its clinical development portfolio, particularly with the drug certepetide, despite challenges in the small-cap healthcare market [2][3] - The company has extended its cash runway into the third quarter of 2026, maintaining a strong financial position with no debt [1][11] Clinical Development Highlights - Certepetide is being evaluated in multiple clinical trials for solid tumors, showing promising results in Cohort A of the ASCEND trial, with a positive trend in overall survival [3][4] - Cohort B results from the ASCEND trial are anticipated soon, with preliminary data accepted for presentation at the ESMO Gastrointestinal Cancers Congress [4] - The BOLSTER trial for cholangiocarcinoma has completed enrollment ahead of schedule, with topline data expected in mid-2025 [4] - The CENDIFOX trial has completed enrollment, providing valuable data for immune profiling and long-term patient outcomes [4] - The iLSTA trial is on track for completion, with preliminary results indicating that certepetide enhances immunotherapy effectiveness [4] Financial Performance - For Q1 2025, operating expenses decreased to $5.8 million from $6.6 million in Q1 2024, a reduction of 11.4% [7] - Research and development expenses were approximately $2.6 million, down 19.7% from $3.2 million in the same period last year [8] - General and administrative expenses slightly decreased to $3.2 million from $3.4 million year-over-year [9] - The net loss for Q1 2025 was $4.7 million, compared to $5.4 million in Q1 2024 [10] Balance Sheet Overview - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling approximately $25.8 million [11] - Total liabilities were reported at $3.9 million, with total equity at $25.1 million [19]

Company Overview - Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [4] - The company's investigational drug, certepetide, aims to enhance the targeting and penetration of anti-cancer drugs in solid tumors through a novel uptake pathway [4] - Lisata has established significant commercial and R&D partnerships based on its CendR Platform® technology [4] Financial Results Announcement - The company will report its financial results for the three months ended March 31, 2025, on May 8, 2025, after the market closes [1] - A conference call will be held at 4:30 p.m. Eastern time on the same day to discuss the financial results [1] Participation in Conference Call - Interested participants must register for the conference call via a provided link and will receive an email with dial-in details [2] - To ensure a smooth experience, participants are encouraged to join the call 15 minutes early [2] Webcast Availability - A live webcast of the conference call will be available on Lisata's website under the Investors & News section [3] - The webcast will be accessible for replay starting two hours after the call and will remain available for 12 months [3] Future Expectations - The company anticipates announcing several milestones over the next 1.5 years and believes its projected capital will support operations into the second quarter of 2026 [4]

"This is another obvious step in the development of Lisata and certepetide as we see great potential in combining both the technologies and the talents of the scientific teams at Lisata and Catalent to study the combination of certepetide and the SMARTag® ADC platform. While ADCs utilize monoclonal antibodies to target tumor-specific antigens ensuring precise delivery of cytotoxic drugs to cancer cells while sparing healthy tissues, combining ADC's with certepetide should ensure that the targeted payload pe ...

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]

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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]

Lisata Therapeutics (LSTA) Q4 2024 Earnings Call February 27, 2025 04:30 PM ET Company Participants John Menditto - Vice President of Investor Relations & Corporate CommunicationsDavid Mazzo - President and Chief Executive OfficerJames Nisco - Senior VP of Finance, Treasurer, CAO & Principal Financial and Accounting OfficerKristen Buck - Executive VP of R&D and Chief Medical OfficerSara Nik - Senior Associate - Equity ResearchPeter Enderlin - Portfolio ManagerSteve Brozak - President & Managing Partner Conf ...

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