Pluri Congratulates Mesoblast on FDA Approval of First Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft-Versus-Host Disease

Rhea-AI Summary

Pluri Inc. (PLUR) congratulates Mesoblast on receiving FDA approval for the first MSC-based therapy treating steroid-refractory acute graft-versus-host disease (SR-aGVHD). This milestone validates the therapeutic potential of Mesenchymal Stromal Cell (MSC) therapies in regenerative medicine. Pluri's CEO Yaky Yanay emphasized how this approval marks a significant advancement in cellular medicine and demonstrates the potential of regenerative therapies to transform healthcare by addressing root causes rather than just symptoms.

Pluri continues developing its proprietary 3D cell-expansion technology for MSC therapies, including PLacental eXpanded cells for treating conditions like Acute Radiation Syndrome and Knee Osteoarthritis.

Positive

• FDA approval of first MSC therapy validates the technology and market potential
• Company's proprietary 3D cell-expansion technology positions it for future developments
• Ongoing development of treatments for multiple conditions shows pipeline diversity

Negative

• None.

Insights

Medical Research Analyst

This FDA approval of Mesoblast's MSC therapy for SR-aGVHD represents a watershed moment in cell therapy regulation. The approval validates MSC therapies' clinical potential and establishes a regulatory precedent that could accelerate future MSC-based treatments. For Pluri, while they're not directly involved, this approval significantly de-risks the regulatory pathway for their PLacental eXpanded cells platform. The market for SR-aGVHD treatment alone is estimated at $300 million annually in the US, but the broader implications for MSC therapies could unlock a multi-billion dollar market. Pluri's technology, focusing on placenta-derived MSCs and their 3D cell-expansion platform, could benefit from this regulatory milestone as it demonstrates the FDA's willingness to approve MSC-based therapies with proven safety and efficacy profiles. For a simplified explanation: Think of this like the first electric car getting approved - it makes it easier for other electric car manufacturers to follow, as regulators now understand the technology better.

Biotech Market Analyst

The market implications of this FDA approval extend far beyond Mesoblast. For Pluri, with its $23.7 million market cap, this development could trigger a sector-wide revaluation of MSC-focused companies. Historical patterns show that pioneering regulatory approvals in novel therapeutic classes often lead to increased investor interest and capital inflow into similar companies. Pluri's proprietary 3D cell-expansion technology could attract particular attention as scalability remains a critical challenge in cell therapy manufacturing. The company's diverse pipeline, including treatments for Acute Radiation Syndrome and Knee Osteoarthritis, might see accelerated development timelines given the newly established regulatory framework. In simple terms: When the first company in a new field succeeds, investors often become more confident in similar companies, potentially leading to higher valuations and easier access to funding for the whole sector.

HAIFA, Israel, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) ("Pluri" or the “Company"), an innovator in the development of leading cell-based technologies for various indications, congratulates Mesoblast Ltd. (“Mesoblast”) and its Chief Executive Officer, Silviu Itescu, on the U.S. Food and Drug Administration (the “FDA”) approval of the first MSC-based therapy for steroid-refractory acute graft-versus-host disease (“SR-aGVHD”). This landmark achievement marks a pivotal moment in the advancement of regenerative medicine and highlights the growing clinical and regulatory recognition of MSC therapies’ transformative potential.

“This milestone is not just a triumph for Mesoblast, but for the entire field of cellular medicine,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “Silviu and the team at Mesoblast have opened a new chapter in harnessing MSC therapies to treat devastating conditions like SR-aGVHD. This approval validates the immense therapeutic promise of MSCs and inspires all of us working in this space to redouble our efforts to bring innovative solutions to patients in need.”

The FDA approval also underscores the critical role of regenerative medicine in transforming healthcare systems globally. “Regenerative medicine has the potential to shift the paradigm from managing chronic conditions to enabling true healing and regeneration,” Mr. Yanay added. “By addressing the root causes of diseases rather than just their symptoms, regenerative therapies can potentially improve patient outcomes while creating more sustainable and efficient healthcare systems.”

Pluri has long championed the potential of MSCs through its proprietary platform, harnessing its unique 3D cell-expansion technology to develop robust and scalable cell-based therapies. The Company’s innovative approach positions it at the forefront of cell therapy development, enabling the creation of next-generation solutions that address critical unmet medical needs.

“At Pluri, we share a vision of a future where cell-based technologies transform lives across a spectrum of diseases,” Mr. Yanay said. “We believe that the FDA’s decision underscores the importance and opportunity to accelerate the development of MSC-based therapies globally.”

Pluri remains steadfast in its mission to expand the therapeutic boundaries of cell-based solutions, leveraging its expertise to pioneer new treatments that meet the highest standards of efficacy, safety, and accessibility. Pluri’s PLacental eXpanded cells are placenta-derived, mesenchymal-like adherent stromal cells which are being studied for the treatment of hematopoietic indications such as Acute Radiation Syndrome as well as orthopedic indications such as Knee Osteoarthritis. For more information about Pluri and its advanced cell therapy product candidates, visit https://pluri-biotech.com/solutions-pluri-health/.

About Pluri Inc.

Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers contract development and manufacturing organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).

Safe Harbor Statement

This press release contains express or implied forward-looking statements within 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 that Mesoblast’s landmark achievement marks a pivotal moment in the advancement of regenerative medicine and highlights the growing clinical and regulatory recognition of MSC therapies’ transformative potential, that regenerative medicine has the potential to shift the paradigm from managing chronic conditions to enabling true healing and regeneration and potentially improve patient outcomes while creating more sustainable and efficient healthcare systems, that the Company’s innovative approach positions it at the forefront of cell therapy development, enabling the creation of next-generation solutions that address critical unmet medical needs, Company’s vision and mission and its belief that the FDA’s decision underscores the urgency and opportunity to accelerate the development of MSC-based therapies globally. These forward-looking statements and their implications are based on the current expectations of the management of Pluri 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 about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. 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

Israel Media: Shachar Yental at shacharye@gitam.co.il

U.S. Media: Jessica Daitch at Jessica@quantum-corp.com

FAQ

What is the significance of FDA's approval of MSC therapy for PLUR's business prospects?

The FDA approval validates the potential of MSC therapies, which is Pluri's core technology, potentially improving market confidence in their development pipeline and technology platform.

What medical conditions is PLUR currently developing treatments for?

PLUR is developing PLacental eXpanded cells for treating Acute Radiation Syndrome and Knee Osteoarthritis.

How does PLUR's 3D cell-expansion technology differentiate it in the MSC therapy market?

PLUR's proprietary 3D cell-expansion technology enables robust and scalable cell-based therapies, positioning the company at the forefront of cell therapy development.

What is the market potential for PLUR's MSC-based therapies following this FDA approval?

The FDA approval of the first MSC therapy validates the market potential for MSC-based treatments, suggesting potential growth opportunities for PLUR's pipeline of cell-based solutions.