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Lisata Therapeutics and GATC Health Consummate First Step in Strategic Collaboration to use AI to Derisk and Accelerate Drug Development

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Lisata Therapeutics (NASDAQ: LSTA) and GATC Health have initiated a strategic collaboration leveraging GATC's AI-powered Multiomics Advanced Technology™ (MAT) platform to optimize and accelerate drug development. The partnership's first phase will analyze Lisata's investigational drug certepetide, focusing on optimizing its Phase 3 development for metastatic pancreatic ductal adenocarcinoma (mPDAC) and identifying new potential indications.

The collaboration will proceed in multiple steps: First, analyzing certepetide's potential applications; second, identifying potential drug combinations across various indications; and finally, establishing Lisata as GATC's operational partner for developing GATC's drug candidates. GATC's MAT AI platform simulates billions of biological interactions to predict safety, efficacy, and clinical trial outcomes.

This partnership aims to address traditional drug development challenges, including high failure rates (1 in 10,000 drugs reach market) and lengthy development timelines, by enabling more focused studies and optimized capital management through AI-driven analysis.

Lisata Therapeutics (NASDAQ: LSTA) e GATC Health hanno avviato una collaborazione strategica sfruttando la piattaforma AI-powered Multiomics Advanced Technology™ (MAT) di GATC per ottimizzare e accelerare lo sviluppo di farmaci. La prima fase della partnership analizzerà il farmaco in fase di sperimentazione di Lisata, certepetide, concentrandosi sull'ottimizzazione del suo sviluppo di Fase 3 per l'adenocarcinoma duttale pancreatico metastatico (mPDAC) e sull'identificazione di nuove potenziali indicazioni.

La collaborazione procederà in più fasi: prima, analizzando le potenziali applicazioni di certepetide; in secondo luogo, identificando potenziali combinazioni di farmaci in diverse indicazioni; e infine, stabilendo Lisata come partner operativo di GATC per lo sviluppo dei candidati farmaci di GATC. La piattaforma AI MAT di GATC simula miliardi di interazioni biologiche per prevedere sicurezza, efficacia e risultati degli studi clinici.

Questa partnership mira ad affrontare le sfide tradizionali dello sviluppo di farmaci, inclusi i tassi di fallimento elevati (1 su 10.000 farmaci raggiunge il mercato) e i lunghi tempi di sviluppo, consentendo studi più mirati e una gestione del capitale ottimizzata attraverso analisi guidate dall'AI.

Lisata Therapeutics (NASDAQ: LSTA) y GATC Health han iniciado una colaboración estratégica aprovechando la plataforma Multiomics Advanced Technology™ (MAT) impulsada por IA de GATC para optimizar y acelerar el desarrollo de medicamentos. La primera fase de la asociación analizará el medicamento en investigación de Lisata, certepetide, centrándose en optimizar su desarrollo de Fase 3 para el adenocarcinoma ductal pancreático metastásico (mPDAC) e identificar nuevas indicaciones potenciales.

La colaboración avanzará en múltiples pasos: primero, analizando las aplicaciones potenciales de certepetide; segundo, identificando combinaciones de medicamentos potenciales en varias indicaciones; y finalmente, estableciendo a Lisata como socio operativo de GATC para el desarrollo de los candidatos a medicamentos de GATC. La plataforma MAT de GATC simula miles de millones de interacciones biológicas para predecir seguridad, eficacia y resultados de ensayos clínicos.

Esta asociación tiene como objetivo abordar los desafíos tradicionales del desarrollo de medicamentos, incluidos los altos índices de fracaso (1 de cada 10,000 medicamentos llega al mercado) y los largos plazos de desarrollo, permitiendo estudios más enfocados y una gestión de capital optimizada a través de análisis impulsados por IA.

리사타 테라퓨틱스 (NASDAQ: LSTA)GATC 헬스는 GATC의 AI 기반 다중 오믹스 고급 기술™ (MAT) 플랫폼을 활용하여 약물 개발을 최적화하고 가속화하는 전략적 협력을 시작했습니다. 파트너십의 첫 번째 단계는 리사타의 임상 시험 약물 서테페타이드를 분석하고, 전이성 췌장관 선암(mPDAC)의 3상 개발을 최적화하며 새로운 잠재적 적응증을 식별하는 데 중점을 둡니다.

협력은 여러 단계로 진행됩니다: 첫째, 서테페타이드의 잠재적 응용을 분석하고; 둘째, 다양한 적응증에서 잠재적 약물 조합을 식별하며; 마지막으로 GATC의 약물 후보 개발을 위해 리사타를 GATC의 운영 파트너로 설정합니다. GATC의 MAT AI 플랫폼은 수십억 개의 생물학적 상호작용을 시뮬레이션하여 안전성, 효능 및 임상 시험 결과를 예측합니다.

이 파트너십은 전통적인 약물 개발의 문제를 해결하는 것을 목표로 하며, 높은 실패율(10,000개 약물 중 1개가 시장에 도달)과 긴 개발 기간을 포함하여 AI 기반 분석을 통해 보다 집중된 연구와 최적화된 자본 관리를 가능하게 합니다.

Lisata Therapeutics (NASDAQ: LSTA) et GATC Health ont lancé une collaboration stratégique en utilisant la plateforme Multiomics Advanced Technology™ (MAT) alimentée par IA de GATC pour optimiser et accélérer le développement de médicaments. La première phase du partenariat analysera le médicament en cours d'investigation de Lisata, certepetide, en se concentrant sur l'optimisation de son développement de Phase 3 pour l'adénocarcinome canalaire pancréatique métastatique (mPDAC) et l'identification de nouvelles indications potentielles.

La collaboration se déroulera en plusieurs étapes : d'abord, en analysant les applications potentielles de certepetide ; ensuite, en identifiant des combinaisons de médicaments potentielles dans diverses indications ; et enfin, en établissant Lisata comme partenaire opérationnel de GATC pour le développement des candidats médicaments de GATC. La plateforme MAT AI de GATC simule des milliards d'interactions biologiques pour prédire la sécurité, l'efficacité et les résultats des essais cliniques.

Ce partenariat vise à relever les défis traditionnels du développement de médicaments, y compris les taux d'échec élevés (1 médicament sur 10 000 atteint le marché) et les délais de développement longs, en permettant des études plus ciblées et une gestion optimisée du capital grâce à une analyse guidée par l'IA.

Lisata Therapeutics (NASDAQ: LSTA) und GATC Health haben eine strategische Zusammenarbeit initiiert, die die KI-gestützte Multiomics Advanced Technology™ (MAT)-Plattform von GATC nutzt, um die Arzneimittelentwicklung zu optimieren und zu beschleunigen. Die erste Phase der Partnerschaft wird das experimentelle Medikament von Lisata, certepetide, analysieren, wobei der Fokus auf der Optimierung seiner Phase-3-Entwicklung für das metastatische duktale Adenokarzinom des Pankreas (mPDAC) und der Identifizierung neuer potenzieller Indikationen liegt.

Die Zusammenarbeit wird in mehreren Schritten erfolgen: Zuerst wird das Potenzial von certepetide analysiert; zweitens werden potenzielle Arzneimittelkombinationen über verschiedene Indikationen hinweg identifiziert; und schließlich wird Lisata als operativer Partner von GATC für die Entwicklung von GATCs Arzneimittelkandidaten etabliert. Die MAT AI-Plattform von GATC simuliert Milliarden biologischer Interaktionen, um Sicherheit, Wirksamkeit und Ergebnisse klinischer Studien vorherzusagen.

Diese Partnerschaft zielt darauf ab, die traditionellen Herausforderungen der Arzneimittelentwicklung anzugehen, einschließlich der hohen Ausfallraten (1 von 10.000 Arzneimitteln erreicht den Markt) und der langen Entwicklungszeiten, indem sie fokussiertere Studien und eine optimierte Kapitalverwaltung durch KI-gesteuerte Analysen ermöglicht.

Positive
  • Strategic partnership with AI technology leader GATC Health
  • Potential optimization of certepetide Phase 3 development
  • Opportunity to identify new drug indications and combinations
  • Expected reduction in development costs and timelines
  • Additional revenue stream as GATC's operational partner
Negative
  • No immediate revenue impact
  • Success of AI analysis not guaranteed
  • Phase 3 development outcomes remain uncertain

Insights

This strategic collaboration between Lisata Therapeutics and GATC Health represents a significant development in AI-driven drug discovery. The partnership leverages GATC's proprietary Multiomics Advanced Technology™ platform to potentially derisk and accelerate Lisata's drug development process, particularly for certepetide, their Phase 3 candidate for metastatic pancreatic ductal adenocarcinoma.

The multi-part agreement offers several potential benefits: (1) optimizing certepetide's development pathway in mPDAC, (2) identifying new indications with higher probability of success, (3) discovering effective combination therapies, and (4) establishing Lisata as an operational partner for GATC's own drug candidates.

From a development perspective, this collaboration addresses a critical industry challenge – the traditional drug discovery process typically costs billions and takes over a decade with only 1 in 10,000 candidates reaching market. By applying GATC's AI platform, Lisata may substantially reduce development risks while improving capital efficiency.

Importantly, GATC's AI technology has already demonstrated value through contributions to novel drug candidates for multiple conditions including addiction, PTSD, diabetes, obesity, glioblastoma, and cognitive decline. The AI's ability to simulate billions of biological interactions and predict safety, efficacy, off-target effects, and trial outcomes could significantly enhance certepetide's development strategy.

While financial terms weren't disclosed, this partnership strategically positions Lisata to potentially enhance its product pipeline while optimizing its existing lead candidate's development path.

The Lisata-GATC collaboration represents a forward-thinking approach to pharmaceutical development that could significantly improve Lisata's risk profile. By applying GATC's validated AI platform to certepetide's development, Lisata potentially gains critical competitive advantages in three key areas.

First, the optimization of certepetide's Phase 3 development in pancreatic cancer could improve trial design and patient selection, potentially increasing success probability in a notoriously difficult indication. Pancreatic cancer trials historically have high failure rates, so any marginal improvement in trial design could translate to meaningful value.

Second, the identification of additional indications through AI analysis could substantially expand certepetide's commercial potential without requiring new molecule discovery. This approach of indication expansion is capital-efficient and leverages existing safety data.

Third, the reciprocal arrangement positioning Lisata as an operational partner for GATC's pipeline creates diversification beyond certepetide while leveraging Lisata's development expertise.

While no financial metrics were disclosed, this deal structure appears designed to create operational efficiencies rather than immediate capital flows. The collaboration's value will ultimately be determined by how effectively the AI platform can predict clinical outcomes and identify viable development pathways.

For a small-cap company ($18M market cap), this type of partnership provides strategic optionality and potential pipeline expansion without significant capital outlay. The collaboration's focus on both optimizing current assets and exploring new opportunities represents a balanced approach to pipeline management.

Strategic collaboration harnesses GATC’s proprietary Artificial Intelligence-powered, validated Multiomics Advanced Technology™ platform to rapidly optimize and derisk drug discovery and development, thereby accelerating and economizing the traditional drug development process.

Lisata’s investigational product, certepetide, to be the subject of a comprehensive AI-analysis to determine optimum disease targets and development strategies.

GATC to leverage Lisata’s experience and operational excellence in translational medicine and drug development to advance their drug candidate pipeline products into clinical trials.

BASKING RIDGE, N.J. and IRVINE, Calif., March 05, 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, and GATC Health Corp (“GATC”), a leading tech-bio company leveraging artificial intelligence (“AI”) to transform drug discovery, today announced the consummation of the first step of an intended multi-part strategic agreement. Under terms of the agreement, the two companies will leverage Lisata’s experience and expertise in drug development together with GATC’s proprietary AI-powered and validated Mutiomics Advanced Technology™ (“MAT”) platform to derisk, optimize, and accelerate drug development, creating opportunities with a higher probability of success.

As the first step in the collaboration, GATC’s MAT AI platform will analyze Lisata’s investigational drug, certepetide, to identify optimized and derisked development opportunities across various indications. GATC’s MAT AI simulates billions of complex systems biological interactions, predicting safety, efficacy, off-target effects, and clinical trial outcomes. Based on the outcome of GATC’s analysis, Lisata plans to optimize its Phase 3 development of certepetide in metastatic pancreatic ductal adenocarcinoma (“mPDAC”) while also identifying new indications with a high probability of development success.

In a subsequent step in the collaboration, GATC’s MAT AI will identify drugs that can be used in combination with certepetide across a wide variety of indications, including those outside of oncology. Finally, the strategic collaboration contemplates the engagement of Lisata as an operational partner of GATC for the development of GATC’s own drug development candidates. To date, GATC’s MAT AI has contributed to the discovery of novel drug candidates targeting addiction, PTSD, diabetes, obesity, glioblastoma, and cognitive decline.

In addition to the practical implications of enhanced and accelerated development, the collaboration is expected to reduce the risks traditionally associated with biopharmaceutical ventures and related investments. By leveraging GATC’s MAT AI platform, drug candidates with a higher probability of success are expected to be quickly identified, thus enabling more focused studies and truncated development timelines along with optimized capital management.

“Lisata is delighted by the prospects of this agreement and is honored to be chosen as a strategic partner by GATC. It is noteworthy that GATC has been selected as the exclusive AI partner of Lloyd’s of London’s syndicate, Medical & Commercial International, and their marketing partner Acrisure, to support the underwriting of the first insurance-backed financial program to fund clinical trials. Additionally, we are excited by the plans for GATC to engage Lisata as a collaborator in the advancement of their own drug development candidates,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. “By combining our expertise with GATC and their cutting-edge AI technology, we are ensuring that Lisata’s and GATC’s development programs have the highest probability of success, allowing us the ability to conduct the most time- and capital-efficient studies to accelerate products to market for the benefit of patients, the medical community, and our shareholders.”

Traditional drug discovery and development is a notoriously risky, expensive, and time-consuming process, often continually projected to take over a decade at a cost of billions of dollars to bring a single therapy to market. The high failure rate, with an estimated 1 in 10,000 identified potential drugs that make it to market, is a direct result of inaccurate target identification, unforeseen toxicity, poor efficacy, and a lengthy, complicated preclinical and clinical trial process. By applying GATC’s MAT AI, drug discovery and development is anticipated to be much faster and more efficient with a greater probability of success.

“GATC’s validated technology inverts predicted clinical trial failures and provides an unbiased analysis of investigational new drugs, such as Lisata’s certepetide,” stated Jayson Uffens, Chief Technology Officer at GATC. “This enables a derisked and optimized development roadmap that can include additional indications and new intellectual property related to the drug candidate. We are also pleased to collaborate with Lisata to leverage their expertise for GATC’s pipeline of assets.”

About Lisata Therapeutics

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into the second quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com.

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

About GATC Health Corp

GATC Health Corp is a technology company revolutionizing drug discovery and development through its transformative AI platform and approach. The company’s validated and proprietary Multiomics Advanced Technology™ (MAT) simulates human biochemistry’s billions of interactions to rapidly create novel therapeutics, identify and confirm targets, accelerate development, and de-risk drug pipelines by predicting efficacy, safety, and off-target effects. For more information, visit www.gatchealth.com.

Forward-Looking Statements

This communication 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 the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with metastatic pancreatic ductal adenocarcinoma and other solid tumors; our beliefs about the potential uses and benefits of certepetide; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 27, 2025, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise.

Lisata Therapeutics Contact:

Investors:
Lisata Therapeutics
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com

Media:
ICR Healthcare
Elizabeth Coleman
Account Supervisor
Phone: 203-682-4783
Email: elizabeth.coleman@icrhealthcare.com

This press release was published by a CLEAR® Verified individual.


FAQ

What is the main objective of Lisata (LSTA) and GATC Health's strategic collaboration?

The collaboration aims to use GATC's AI-powered MAT platform to optimize and accelerate drug development, focusing initially on analyzing Lisata's certepetide for various indications including mPDAC.

How will GATC's AI technology benefit Lisata's (LSTA) certepetide development?

GATC's MAT AI will analyze certepetide to optimize Phase 3 development in mPDAC, identify new indications, and determine potential drug combinations across various therapeutic areas.

What are the expected outcomes of the Lisata-GATC collaboration for drug development timelines?

The collaboration aims to reduce development timelines and costs while increasing success probability through AI-driven analysis and focused studies.

How will Lisata (LSTA) contribute to GATC Health's drug development program?

Lisata will serve as an operational partner for GATC, leveraging its experience in translational medicine and drug development to advance GATC's drug candidates.
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