Pluri and Remedy Cell Expand Collaboration; Successful Engineering Runs and Clinical-Grade Manufacturing Achieved
HAIFA, Israel, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Pluri, Inc. ("Pluri", the "Company", "we" or "us") (Nasdaq, TASE: PLUR), a leading biotechnology company leveraging its proprietary platform for cell-based solutions through a collaborative network of ventures, today announced expansion of its manufacturing agreement signed in 2024 with Remedy Cell Ltd. ("Remedy Cell"), an innovative biopharmaceutical company developing stem cell-derived, cell-free therapeutics for complex fibrotic conditions.
Under the ongoing collaboration Remedy Cell's personnel, along with Pluri's Contract Development and Manufacturing Organization ("CDMO") division (PluriCDMO™), have successfully completed the full implementation of Remedy Cell's proprietary manufacturing process into Pluri's state-of-the-art Good Manufacturing Practice ("GMP") facility, conducted GMP training and qualification for the Remedy Cell manufacturing team, executed engineering runs to confirm process robustness and scalability, and manufactured several clinical-grade batches of Remedy Cell's lead candidate. These batches are intended for use in Remedy Cell's initial Phase 1b clinical trial, representing a major step in its clinical development. This achievement reflects the strong synergy between Remedy Cell's innovative therapeutic platform and Pluri's advanced manufacturing facilities.
The completion of these activities demonstrates PluriCDMO™'s potential to serve complex cell-derived and cell-free processes with consistent, scalable, and regulatory-compliant manufacturing solutions. For Remedy Cell, this milestone marks tangible progress on its path toward clinical development and the realization of its mission to bring secretome-based therapies to patients with fibrotic diseases.
Building on this success, Pluri and Remedy Cell are now broadening the scope of their collaboration. PluriCDMO™ will continue to provide additional manufacturing and process-development support as Remedy Cell advances its clinical and pre-commercial programs. The expanded activity underscores the productive partnership between the teams and their shared commitment to advancing next-generation, cell-free biologics that address significant unmet medical needs.
"Working with Pluri has been highly productive," said Ayelet Dilion-Mashiah, Chief Executive Officer of Remedy Cell. "Pluri's expertise and professionalism have been invaluable in helping us reach this critical milestone. Completing our clinical-grade manufacturing and preparing for our first clinical trial is a defining achievement for Remedy Cell, and we look forward to continuing this productive partnership."
"We are proud to continue strengthening our agreement with Remedy Cell, working together to achieve every project milestone — from technology implementation and engineering runs to the successful manufacture of clinical-grade batches for their first human trial," said Yaky Yanay, Chief Executive Officer and President of Pluri. "Remedy Cell's scientific approach is highly innovative, and it has been a privilege to contribute to their progress. This success further positions PluriCDMO™ as a trusted partner for companies developing complex, cell-derived therapies."
About Pluri Inc.
Pluri™ is a biotechnology company pioneering mass-scale cell expansion and biofarming. Using its patented, proprietary 3D cell expansion platform, Pluri develops scalable, consistent, and cost-efficient cell-based solutions. The Company drives innovation in regenerative medicine, foodtech, agtech, and offers CDMO services. With two decades of experience, a strong intellectual property portfolio and its collaborative network of ventures, Pluri accelerates breakthroughs that address global challenges such as sustainable food production, healthcare, and climate resilience. To learn more, visit www.pluri-biotech.com or follow Pluri on LinkedIn and X.
About PluriCDMO™
Pluri launched its CDMO division in January 2024, leveraging its proprietary knowledge, cutting-edge technology and cell therapy production facility on behalf of clients. PluriCDMO™ clients gain access to Pluri's state-of-the-art GMP facilities, and to Pluri's patented bioreactor system, which enables cell expansion at mass scale via a fully controlled, automated and validated process. For more information visit www.pluri-biotech.com/cdmo or contact [email protected]
About Remedy Cell Ltd.
Remedy Cell Ltd., is a clinical stage biopharmaceutical company revolutionising fibrotic disease treatment with cell-derived, cell-free breakthrough therapies. The company's proprietary Activated Remedy Cell Secretome (ARcS) platform delivers multi-target, pro-regenerative solutions for complex fibrotic conditions. The company's lead product, RC-0315, a first-in-class activated MSC-derived secretome therapy for of Idiopathic Pulmonary Fibrosi ("IPF"), has shown in definitive preclinical studies the potential to repair lung tissue and restore function. IPF is a fatal, highly complex and progressive interstitial lung disease affecting approximately 3 million people worldwide. With a median survival of only 2-5 years post-diagnosis. Despite the considerable impact of these diseases, current therapeutic options remain limited in both efficacy and scope, creating an urgent need for innovative approaches. To learn more, visit www.remedycell.com or follow Remedy Cell on LinkedIn.
Forward-Looking Statements
This press release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the expectation that the clinical-grade batches of Remedy Cell's lead candidate will be used in Remedy Cell's initial Phase 1 clinical trial; the belief that the completion of the listed activities reflects PluriCDMO's proven ability to serve complex cell-derived and cell-free processes with consistent, scalable, and regulatory-compliant manufacturing solutions; Remedy Cell's ability to progress on its path toward clinical development and the realization of its mission to bring secretome-based therapies to patients with fibrotic diseases; Pluri and Remedy Cell's ability to broaden the scope of their agreement, including Pluri's ability to provide additional manufacturing and process-development support, and Remedy Cell's ability to advance its clinical and pre-commercial programs; and the expectation that Pluri's and Remedy Cell's underscore the productive partnership between the teams and their shared commitment to advancing next-generation, cell-free biologics that address significant unmet medical needs. . These forward-looking statements and their implications are based on the current expectations of Pluri's and Remedy Cell's management only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in consumer preferences or aesthetics industry trends; Pluri or each of its subsidiaries may encounter delays or obstacles in the launch, development, manufacturing, or commercialization of its food/agtech products; regulatory hurdles in new markets; the efficacy or safety of cell-derived products may not meet expectations; shifts in strategic priorities by Pluri or its partners/collaborators, including these global food and agtech companies; challenges in marketing or brand alignment; intellectual property risks; unforeseen scientific or operational difficulties; inability to attract or retain key personnel; and competitive pressures that could impact market adoption or pricing. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri, reference is made to Pluri's reports filed from time to time with the Securities and Exchange Commission.
Contacts
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U.S. Media: Berry Brady at [email protected]
Israel Media: Shachar Yental at [email protected]
