Pluri and Remedy Cell Expand Collaboration; Successful Engineering Runs and Clinical-Grade Manufacturing Achieved

Rhea-AI Summary

Pluri (Nasdaq, TASE: PLUR) and Remedy Cell announced an expanded manufacturing collaboration on Dec 22, 2025. PluriCDMO completed implementation of Remedy Cell’s proprietary process in its GMP facility, provided GMP training and qualification, executed engineering runs to confirm process robustness and scalability, and manufactured several clinical-grade batches of Remedy Cell’s lead candidate for a planned Phase 1b clinical trial.

The companies will broaden the agreement so PluriCDMO continues providing manufacturing and process-development support as Remedy Cell advances clinical and pre-commercial programs, positioning PluriCDMO as a CDMO partner for complex cell-derived and cell-free biologics.

Positive

• Completed GMP process implementation in Pluri’s manufacturing facility
• GMP training and qualification completed for Remedy Cell team
• Engineering runs confirmed process robustness and scalability
• Manufactured several clinical-grade batches for a Phase 1b trial
• Expanded PluriCDMO support for clinical and pre-commercial programs

Negative

• None.

Key Figures

Resale shares registered 3,425,488 shares Shares covered by shelf resale registration

Shares outstanding 8,155,948 shares Outstanding as of Sep 16, 2025

Potential warrant proceeds $724,686 If certain outstanding warrants and pre-funded warrants are exercised for cash

Warrant exercise price $5.568 Exercise price for specified warrants

Pre-funded warrant price $0.00001 Exercise price for specified pre-funded warrants

Stock option exercise prices $10.40 and $18.72 Weighted average exercise prices for certain stock options

Warrant-related shares 2,151,809 shares Shares issuable upon exercise of warrants/pre-funded warrants at $4.27 avg

RS/RSU shares 564,564 shares Shares issuable upon vesting of RS/RSUs

Market Reality Check

$3.40 Last Close

Volume Volume 35,453 is 20% below the 20-day average of 44,222, suggesting limited pre-news participation. normal

Technical Price $3.40 is trading below the 200-day MA of $4.51, reflecting a weak longer-term trend.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-09-17

$724,686 registered capacity

An effective S-3 shelf dated Sep 17, 2025 covers resale of 3,425,488 shares and discloses potential proceeds of $724,686 if specified warrants and pre-funded warrants are exercised for cash. The company will not receive proceeds from shareholder resales but could receive cash from warrant exercises, indicating possible future share issuance.

Market Pulse Summary

This announcement highlights that PluriCDMO™ completed technology transfer, engineering runs, and clinical-grade manufacturing for Remedy Cell’s lead candidate, supporting its planned Phase 1b trial. Pre-news, PLUR traded around $3.40, well below its 52-week high of $7.13 and under the 200-day MA of $4.51. An active S-3 for 3,425,488 resale shares and additional warrant/RSU overhang are key structural factors investors may monitor alongside future CDMO updates.

Key Terms

good manufacturing practice regulatory

"Pluri’s state-of-the-art Good Manufacturing Practice (“GMP”) facility"

Good manufacturing practice (GMP) are the rules and routines companies must follow to make products consistently safe and effective, covering everything from equipment and cleanliness to staff training and recordkeeping. For investors, GMP compliance signals lower risk of product failures, regulatory fines, production stoppages or costly recalls—like a reliable recipe and tidy kitchen that help ensure every batch turns out the same and customers stay satisfied.

gmp regulatory

"conducted GMP training and qualification for the Remedy Cell manufacturing team"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

cdmo technical

"Pluri’s Contract Development and Manufacturing Organization (“CDMO”) division (PluriCDMO™)"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

phase 1b medical

"intended for use in Remedy Cell’s initial Phase 1b clinical trial"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

secretome-based medical

"bring secretome-based therapies to patients with fibrotic diseases"

Secretome-based describes therapies or products that use the mixture of proteins, small molecules and vesicles naturally released by cells (the “secretome”) rather than the cells themselves. Think of it as using a cell’s signal soup to trigger healing or change without transplanting living cells; for investors this can mean simpler manufacturing, different safety and regulatory profiles, and distinct commercial risks and opportunities compared with cell-based approaches.

AI-generated analysis. Not financial advice.

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 CDMO@Pluri-biotech.com

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

Investors: investor.relations@pluri-biotech.com
U.S. Media: Berry Brady at berry@quantum-corp.com
Israel Media: Shachar Yental at shacharye@gitam.co.il

FAQ

What did Pluri (PLUR) and Remedy Cell announce on December 22, 2025?

They announced an expanded manufacturing collaboration after PluriCDMO implemented Remedy Cell’s process, completed GMP training, ran engineering batches, and manufactured clinical-grade lots for a Phase 1b trial.

Does the PluriCDMO manufacturing support include GMP training for Remedy Cell (PLUR)?

Yes; PluriCDMO provided GMP training and qualification for the Remedy Cell manufacturing team.

What stage are Remedy Cell’s manufactured batches intended for according to Pluri (PLUR)?

The manufactured clinical-grade batches are intended for Remedy Cell’s initial Phase 1b clinical trial.

Will Pluri (PLUR) continue supporting Remedy Cell after the initial batches?

Yes; the companies expanded the agreement so PluriCDMO will provide additional manufacturing and process-development support as programs advance.

What manufacturing milestones did Pluri (PLUR) achieve for Remedy Cell’s lead candidate?

Pluri completed process implementation, executed engineering runs to confirm scalability, and produced several clinical-grade batches.